BioPharma Today

J&J Taking The Long View With Its Therapeutic Franchises

Fri, 24 May 2013 14:55:01 PDT

The Big Pharma has only recently entered the diabetes drug market, but has plans to make a significant impact on how the disease is treated. During a meeting with analysts, J&J highlighted the deals it’s made and the multiple indications it will pursue within the metabolic space.

Second Phase Of Takeda’s Globalization Plan Calls For Partial Integration Of Millennium

Fri, 24 May 2013 14:35:01 PDT

The next phase of Takeda’s globalization strategy emphasizes organizational house cleaning. Millennium, which had operated as a standalone oncology outpost, will be partially integrated into Takeda R&D but the commitment to oncology in terms of resources and investment remains firm.

Recent Violence Targeted At Doctors In China Could Spell Trouble For Clinical Trials

Fri, 24 May 2013 13:35:01 PDT

Amid tense doctor-patient relations, high-profile adverse events in clinical trials have put strains on an already challenging environment for drug development in China.

Merck Halts Preladenant Development In Parkinson’s Following Phase III Failures

Fri, 24 May 2013 13:05:00 PDT

Company says it will not pursue regulatory filings for the adenosine-2a receptor antagonist because studies in moderate-to-severe and early-stage disease failed to show sufficient evidence of efficacy.

Third Rock’s Mark Levin Warns of System-Wide Failure To Support Young Biomedical Companies

Fri, 24 May 2013 12:15:01 PDT

Third Rock Partner Mark Levin is excited about emerging science, but somewhat pessimistic about the environment for companies pursuing it.

War Of Words: Pfizer Battles With Top Indian Pharma Lobby On Key Policy Issues

Fri, 24 May 2013 11:35:00 PDT

Pfizer counters assertions by the Indian Pharmaceutical Alliance that the U.S. company misled a congressional hearing about India’s deteriorating IP environment. With hard-hitting statements coming from both sides, the gloves have come off.

Let The Blame Game Begin: Former Ranbaxy Promoter Spars With Daiichi Sankyo

Fri, 24 May 2013 11:05:00 PDT

PharmAsia News speaks to former CEO Malvinder Singh and U.S. whistleblower Dinesh Thakur, as the stakes continue to rise in the ongoing saga of India’s Ranbaxy.

Repros Needs Another Mid-Stage Trial For Proellex In Uterine Fibroids

Fri, 24 May 2013 10:15:01 PDT

FDA also recommends longer-duration Phase III trials of the vaginally-administered selective progesterone receptor modulator than the sponsor envisioned. Primary endpoint will measure blood loss; agency stresses that bulk symptoms and other patient-reported outcomes will first need validation.

India Adopts Guidelines To Comply With EU Drug-Quality Import Rules

Fri, 24 May 2013 01:40:03 PDT

India drug regulators issued new GMP guidelines, effective July 2, for complying with demands by the European Union covering exports of APIs to its 27 member nations.

J&J Pakistan Seeks Buyer As MNCs Reconsider Local Market

Fri, 24 May 2013 01:35:02 PDT

Johnson & Johnson Pakistan is looking for a buyer for the subsidiary, which produces Janssen brands locally for the Pakistan market, according to sources.

Saudi Arabia Cites Foreign Patents Of Coronavirus For Slowing Diagnosis

Fri, 24 May 2013 01:25:01 PDT

Saudi Arabia health authorities accused foreign researchers of slowing its ability to diagnose a SARS-like virus that has affected the country and has killed 22 people globally within the past year.

Emerging Company In An Emerging Market: Generon Sees Quality And Price As Litmus Test

Thu, 23 May 2013 23:00:01 PDT

Generon in Shanghai was founded by former Hutchison MediPharma employees to target a niche market between expensive import drugs and lower quality domestic products.

Guangdong May Group Drugs Into Five Types For Separate Price Review

Thu, 23 May 2013 22:00:00 PDT

Guangdong has released its pharma procurement draft rules for consultation, stating it would use a third-party online platform to request EDL drug tenders for all public hospitals.

J&J Sees New MOAs For Refractory Populations As Anti-Depressant For Neuro Sales

Thu, 23 May 2013 20:25:02 PDT

J&J’s five key therapeutic areas appear to be operating on all cylinders, based on presentations at the company’s annual analyst meeting. In neuroscience, already one of its core fields, it is expanding its anti-psychotic and mood disorders franchise to focus on difficult-to-treat patients, as well re-doubling efforts in challenging diseases like Alzheimer’s disease.

Compounding Legislation Remains Stuck On Definitions Even As House Budges

Thu, 23 May 2013 20:20:00 PDT

Rep. Griffith is drafting legislation based on the guidance FDA had in development before the NECC crisis struck, but the agency says it was not intended to fix its oversight problems, and FDA is also expressing dissatisfaction with the Senate’s bipartisan compounding bill.

Nearly All Drugs Pass China’s Second National Drug Quality Report For 2013

Thu, 23 May 2013 19:00:00 PDT

The Second Drug Quality Announcement of 2013 was released by China FDA, reporting that 99.3% of the 2,885 batches of 18 drugs passed evaluations.

Singh Brothers Deny Concealing Info From Daiichi Sankyo At Ranbaxy Sale

Thu, 23 May 2013 15:45:04 PDT

The Singh brothers who sold Ranbaxy Laboratories to Daiichi Sankyo denied accusations they concealed and misrepresented the status of a U.S. investigation of the company at the time of the sale.

Glenmark Recalls Three Drugs In U.S. For Bad-Smelling Containers

Thu, 23 May 2013 15:40:04 PDT

Glenmark Generics announced a recall of three of its drugs from the U.S. market after receiving complaints of a bad odor in bottles containing the pills.

Solomon To Step Aside As Forest Exec; Icahn Wins Another Victory

Thu, 23 May 2013 15:35:05 PDT

President and CEO of Forest Laboratories Howard Solomon will retire at the end of the year. Activist investor Carl Icahn has long inveighed against the 85 year-old exec.

J&J Eyes Brazil, China, India, Other Emerging Markets For 10-Drug Rollout

Thu, 23 May 2013 15:30:01 PDT

Johnson & Johnson is targeting Brazil, China, India and other emerging markets for a planned global rollout of 10 new drugs by 2017, in addition to improving more than 25 existing ones.

FDA’s Root Cause Investigation Into Bupropion Trouble Could Have Broad Implications For Generics

Thu, 23 May 2013 14:15:00 PDT

Agency is now turning to outside researchers for studies to determine why Impax and Teva’s 300 mg bupropion generic failed and what that might mean for generics as a whole.

BTG Makes Two Buys To Build Interventional Medicine Business

Thu, 23 May 2013 13:15:01 PDT

BTG of Britain plans two new acquisitions, including a therapy for liver cancer that uses radioactive glass beads and a treatment for dissolving severe blood clots. The deals create an interventional medicine business with potential sales of $1 billion; BTG is funding much of the exercise through a share placement.

More Indian Sites Under U.S. FDA Lens? Wockhardt Slapped With Import Alert On Injectables Site

Thu, 23 May 2013 10:00:01 PDT

In the wake of the Ranbaxy settlement, Wockhardt is the latest Indian company to be issued an import alert for alleged GMP violations.

South Korea Starts Onsite Inspections Of Essential Drug Reserves Amid Tension With North Korea

Thu, 23 May 2013 08:20:00 PDT

As tensions between South and North Korea simmer, South Korea is conducting its first on-site inspections of drug reserves since 2006.

Russia Seeks Foreign Partnerships For Pharma, Medical Device Growth

Wed, 22 May 2013 23:50:00 PDT

Drugs and medical devices are the subject of several efforts Russia is making to attract international partnerships to help the country achieve several goals, including one to produce nearly half such products it consumes.

ViroCyt LLC

Wed, 22 May 2013 21:01:36 PDT

Typical methods for detecting viruses in a biochemical sample can take days, or even weeks, to produce results and frequently, especially in vaccine production, producers are doing it blind for a period of time, not knowing how productive or successful the current batch is. ViroCyt LLC aims to produce results in real time: its Virus Counter is designed to provide accurate virus counts in a sample within 10 minutes, saving protein and vaccine manufacturers time and money.

Out Of The Blocks, May 2013

Wed, 22 May 2013 21:01:31 PDT

Brief profiles of these recently formed companies: advanceCOR, Aegis Women’s Health Technologies, dBMEDx, Exscien, OsteoVantage, and Trice Orthopedics.

Room For HCV-Focused Start-Ups If The Technology Is Truly Novel

Wed, 22 May 2013 21:01:21 PDT

Hepatitis C has been the focus of some of biopharma’s most expensive deals the past couple years. In the wake of the licensing, IPO, and M&A frenzy, not many new start-ups have emerged, but there are a still a few niches to fill if entrepreneurs can find funding.

Emergings In Brief, May 2013

Wed, 22 May 2013 21:01:13 PDT

Brief profiles of these recently formed companies: advanceCOR; Aegis Women’s Health Technologies, Exscien, and Trice Orthopedics.

Start-Up Previews, May 2013

Wed, 22 May 2013 21:01:04 PDT

This Month's Profile Group: Women’s Health: Moving Beyond Gynecology To Sexuality, features profiles of Evestra Pharmaceuticals, S1 Biopharma, and Sprout Pharmaceuticals. Plus these Start-Ups Across Health Care: AgPlus Diagnostics, MitaMed, Respinova, and ViroCyt.

A New Direction For Alzheimer’s R&D: FDA Outlines Early Disease Pathway

Wed, 22 May 2013 21:00:45 PDT

Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of the disease, and FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.

Biopharma Dealmaking Quarterly Statistics, Q1 2013

Wed, 22 May 2013 21:00:29 PDT

Biopharma financing reached $4.6 billion in Q1 2013, exceeding Q4 2012’s $4.2 billion total, mostly through follow-on public offerings, which made up 47% of the total funding. Conversely, M&A was on the decline with 18 completed transactions together valued at $4.8 billion, the lowest quarter since 2009.

Execs On The Move, May 2013

Wed, 22 May 2013 21:00:25 PDT

Recent executive-level company changes and promotions in the biopharma, medical device, and diagnostics industries.

Start-Up Quarterly Statistics, Q1 2013

Wed, 22 May 2013 21:00:11 PDT

Start-up company fundraising got off to a slow start in 2013: life sciences companies brought in $398.7 million, roughly 59% less than in the final quarter of 2012. Of the total raised, 84% went to biopharmas.

Start-Up Execs On The Move, May 2013

Wed, 22 May 2013 21:00:07 PDT

Recent executive-level hires and director appointments at venture capital firms and biopharma, medtech, and diagnostics start-ups.

Deals In Depth: March 2013

Wed, 22 May 2013 21:00:02 PDT

AstraZeneca paid $240 million for rights to Moderna’s RNA therapeutics. Argon Medical acquired Angiotech’s interventional business for $362.5 million.

Suvorexant’s “Twilight Zone”: Advisory Panel, FDA Favor Low Dose; Merck Does Not

Wed, 22 May 2013 20:50:03 PDT

FDA and its advisors seem to support lowering the proposed dose for Merck insomnia treatment suvorexant as a way to save the marketing application, but Merck appears insistent that the lower 10 mg dose doesn’t work.

Rx Supply Chain Bill On Track In Senate; Will House Use The Same Gauges?

Wed, 22 May 2013 20:50:00 PDT

Track-and-trace measure goes to floor coupled to compounding bill, but the all-smiles markup in the Senate HELP Committee is more than made up for by the differences that remain with the House version.

Japan 2012 Drug Sales Ended Nearly Flat On Price Revision, Generic Promotion: IMS Japan

Wed, 22 May 2013 20:20:01 PDT

Japan’s prescription drug market achieved sales of ¥9.56 trillion ($93 billion), a 0.3% increase from the previous year, according to a survey by IMS.

Bayer Files Application For First Chronic Thromboembolic Pulmonary Hypertension Drug In Japan

Wed, 22 May 2013 20:00:03 PDT

Bayer has filed for the approval of riociguat, the first chronic thromboembolic pulmonary hypertension, or CTEPH drug, in Japan.

Recent Violence Targeted At Doctors In China Could Spell Trouble For Clinical Trials

Wed, 22 May 2013 16:45:01 PDT

Amid tense doctor-patient relations, high-profile adverse events in clinical trials have put strains on an already challenging environment for drug development in China.

Ahead Of Schedule, Pfizer Prepares To Set Zoetis Free In Stock Swap

Wed, 22 May 2013 16:10:06 PDT

The Big Pharma intends to loosen its leash on its former animal health business come June when Pfizer shareholders will be given an option to swap their shares for Zoetis stock. Meanwhile, Pfizer continues its strategy to shift its focus back to the core pharmaceutical business.

Ranbaxy Said To Mull Cuts In Global Sales Staff, Mainly In U.S.

Wed, 22 May 2013 16:10:03 PDT

Troubled Ranbaxy Laboratories plans to reduce its global sales force of 14,600, most of them in the U.S. where its latest problems have occurred, a source said.

NICE Rejects Avastin For Ovarian Cancer On Cost, Okays Lucentis

Wed, 22 May 2013 15:40:01 PDT

NICE has knocked back Avastin for ovarian cancer due to high cost, but Roche may have a plausible market strategy in place for the drug in the UK.

Pfizer Guards Viagra Sales, Moves Against Tainted Supplements

Wed, 22 May 2013 14:45:01 PDT

A Pfizer study that finds 81% of sexual performance products claiming to be natural have undeclared pharmaceuticals could pressure FDA to increase enforcement and Congress to boost funding for the effort. The firm also launches online sales of Viagra to combat sales of counterfeit erectile dysfunction drugs.

Compounding Bill Glides Toward Senate Floor; FDA Gets More Flexibility On Fees

Wed, 22 May 2013 14:20:00 PDT

Senate HELP Committee attaches amended compounding bill to track-and-trace legislation as Sen. Isakson lists three remaining concerns.

Mylan: Brand/Generic Distinction Disintegration Is Necessary

Wed, 22 May 2013 13:35:01 PDT

Consolidation in the generic industry is good and necessary, Mylan CEO Heather Bresch said during a recent investor presentation. Mylan is well-positioned in the changing market, she said, thanks to business development such as its biosimilars agreements with Biocon and its Japan collaboration with Pfizer.

Stand-Alone Part D Plans Subject To Medical Loss Ratio Checks, CMS Confirms

Wed, 22 May 2013 12:05:00 PDT

Drug firms and insurers are concerned that the standards may put too much pressure on Medicare prescription drug plans and jeopardize the ability of some plans to continue operating.

Final Assault: Daiichi Sankyo Threatens Legal Action Against Former Ranbaxy Shareholders For Concealing Information

Wed, 22 May 2013 11:55:04 PDT

Breaking its silence after four years, Daiichi Sankyo hinted for the first time that it would pursue legal remedies against former shareholders of Ranbaxy, which the Japanese company bought in 2008 to expand into emerging markets and the generics drug space.

In India, Roche’s Herceptin Strategy Collides With Mylan

Wed, 22 May 2013 10:50:01 PDT

On an appeal from Mylan, patent authorities in Kolkata warned Roche to respond within 10 days on the status of its Herceptin divisional patents or claims will be deemed to be withdrawn and abandoned.

Asia On The Move: Personnel News From Roche, Astellas And Pfizer

Wed, 22 May 2013 07:20:00 PDT

China’s National Health and Family Planning Commission appoints eight deputy commissioners. Astellas hires a global head of pharmacovigilance from rival Takeda, while Chinese domestic drug makers lure executives away from multinational firms.

Has Ranbaxy Damaged India’s Pharma Brand?

Wed, 22 May 2013 06:30:01 PDT

Indian generics manufacturers are worried that Ranbaxy’s recent guilty plea to criminal charges in the U.S. could make it more difficult for other Indian pharma companies to win new contracts with U.S. wholesalers.

CFDA Announces Overall Plans For Staffing, Internal Structures, Duties

Wed, 22 May 2013 01:05:01 PDT

The State Commission Office for Public Sector Reform announced the overall plans on the newly established China FDA’s staffing, internal structure, and main duties.

Chinese City’s Disease Control Center Illegally Tenders For Type II Vaccines

Wed, 22 May 2013 00:55:04 PDT

Hunan’s department of health has cracked down on Huanggang City’s disease control center for illegally launching tender requests for lucrative type-II vaccines at RMB 120 million ($19.3 million) May 15 in the first ever city-level request which attracted over 30 companies.

CFDA Announces Schedule For E-Monitoring Of New EDL Drugs

Wed, 22 May 2013 00:50:00 PDT

China FDA announced plans to incorporate new formulary drugs, whether sold in public health institutes or not, into the electronic monitoring system.

GSK To Shut Australia Tablet Plant, Shift Operations To Spain, Poland

Wed, 22 May 2013 00:20:02 PDT

GlaxoSmithKline said it would close its tablet-packaging plant in Melbourne, Australia, eliminating 120 jobs within the next two years.

India Cancels Plan Of Free Generics At Hospitals, Health Centers

Wed, 22 May 2013 00:15:03 PDT

India has canceled a plan of providing free generic drugs at the nation's hospitals and health centers because of an inability to formulate a drug-procurement policy along with financial restraints.

India Orders Own Probe Of Ranbaxy's Approved Drugs Backgrounds

Tue, 21 May 2013 15:50:00 PDT

India's health ministry has decided to conduct its own probe of Ranbaxy Laboratories, beginning with close examination of all of the company's approved drugs, focusing on dossiers and applications.

Japan Plans Increase In Drug-Review Staff To Speed Approvals

Tue, 21 May 2013 15:40:03 PDT

Japan's Pharmaceuticals and Medical Devices Agency plans to nearly double its staff of 708 over the next five years as one way to speed the nation's approval of marketing applications.

A Trio Of Strategic VCs Helps To Back Effector Therapeutics With $45 Million

Tue, 21 May 2013 15:05:00 PDT

Using technology spun out of UCSF, a new company hopes to develop oncology drugs that target effector mechanisms of protein synthesis, thereby affecting multiple oncogenes simultaneously. The San Diego-based biotech also hopes to license out its platform for non-cancer indications, bringing in non-dilutive money.

Everything REMS Under The Sun: FDA Lays Out Ambitious PDUFA V Meeting Agenda

Tue, 21 May 2013 14:55:00 PDT

The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.

As India Finalizes New Pricing Policy, Analysts Focus On Potential Winners And Losers

Tue, 21 May 2013 14:25:00 PDT

With a new market-based policy in place, prices of leading brands will fall in the short term but losses may be mitigated by tiered pricing and better patient engagement in the long run.

Karyopharm Scores $48M Series B To Advance Early Cancer Compounds

Tue, 21 May 2013 13:50:00 PDT

The Massachusetts biotech has remained well-funded despite shying away from venture capital investors and seeking funds from private investors.

Drug Development Needs “Clean-Slate Think” To Involve Patients All Along The Way – Pfizer’s Lewis-Hall

Tue, 21 May 2013 13:20:01 PDT

Drug companies and other stakeholders should collaborate on developing a “clear framework” for patient engagement, Freda Lewis-Hall says at ISPOR.

Bothering To Look: With New Tools, Biotech Goes Back To The Black Box

Tue, 21 May 2013 12:10:01 PDT

For decades drug discovery meant testing new compounds in cells and animals without knowing how or why they might work. A shift to reductionist, target-based discovery has done little to nothing to bring more drugs to market.

Norway’s Xellia Pharma Acquired By Novo A/S In $700 Million Buyout

Tue, 21 May 2013 11:55:01 PDT

3i sells Nordic antibacterial manufacturer Xellia Pharmaceuticals, which has plans to develop novel antibiotics, new formulations and new bulk generics.

Drug Discovery, Step By Step

Tue, 21 May 2013 11:00:01 PDT

At risk of being reductive, START-UP asked Myelin Repair Foundation Chief Scientific Officer Mike Gresser, PhD, to outline two drug-discovery approaches: One that starts with a molecular target then finds drugs to match it, the other that starts phenotypically, by pursuing the biological effects of a compound in living systems. There is overlap; there’s no such thing as strictly phenotypic drug discovery or target-based discovery. “In a target-based approach, researchers first identify a promising molecular target by any of several means: Find genetic alterations in humans or other anim...

AstraZeneca Shakeup Of China Business Unit Steers Focus Away From Generics To Innovative Drugs

Tue, 21 May 2013 10:20:05 PDT

AstraZeneca will dissolve its Broad Market business unit in China by merging it with primary care and move away from attracting business for branded generics in tier-3 rural markets, putting flesh on new CEO Pascal Soriot’s plan to focus on innovation.

MedWatch’s Patient-friendly Reporting Form Might Need An Overhaul

Tue, 21 May 2013 10:00:01 PDT

Promotion of the consumer MedWatch form needs to be improved if more physicians and consumers are to use it, FDA’s Risk Communications Advisory Committee says.

FDA’s Social Media Messages Should Be Pretested, Risk Communication Advisors Say

Tue, 21 May 2013 09:45:01 PDT

Risk Communication Advisory Committee members express support for FDA’s social media plans, but emphasize the importance of pretesting messages and studying the impact of agency efforts.

Mixing Business And Philanthropy Yields Returns For Glaxo In Africa

Tue, 21 May 2013 08:45:00 PDT

GlaxoSmithKline is having success with its "hybrid" approach in Africa, combining no-nonsense business with the aim of improving access to medicines there – in part through deeply discounted prices, measuring managers’ sales performances by the amount of drugs sold, rather than profits, and reinvesting in health infrastructure.

Japan Pharma Annual Meeting Snapshot: Eisai, Dainippon, Shionogi, Ajinomoto, Astellas

Tue, 21 May 2013 07:55:01 PDT

The annual earnings meetings of Eisai, Dainippon Sumitomo, Shionogi, Ajinomoto and Astellas highlight critical issues impacting Japanese pharma, from the evolving domestic generics market, choosing whether to enter the biosimiliars fray and the impact of yen depreciation on reimbursement pricing.

Jubilant Lifesciences Orders U.S. Recall Of Acid-Reflux Indian Generic

Tue, 21 May 2013 00:40:03 PDT

Jubilant Cadista announced a recall of the delayed-release version of its pantoprazole generic acid-reflux drug from the U.S. market, citing good manufacturing practices violations at its India plant.

Takeda-Lundbeck Antidepressant Shows Promise In Final U.S. Trial

Tue, 21 May 2013 00:35:00 PDT

Takeda Pharmaceutical's Brintellix (vortioxetine) antidepressant, which it is developing in the U.S. with Denmark's H. Lundbeck, has shown in a Phase III trial to be successful in improving symptoms.

Toyama Chemicals Acquires Rights To New Macrolide Antibiotic Solithromycin From U.S. Firm Sempra

Tue, 21 May 2013 00:15:00 PDT

Fuji Film Group announced its affiliate Toyama Chemicals acquired exclusive rights for the development, manufacture, and sale of the new macrolide antibiotic solithromycin from the American company Sempra.

Abilify And Six New Drugs Push Otsuka’s 2012 Results Up 7.8%

Tue, 21 May 2013 00:05:03 PDT

Otsuka Holdings announced 2012 Japan sales results of ¥351.8 billion ($3.4 billion), a 7.8% increase from the previous year.

AstraZeneca And BMS Launch First Once-Weekly Bydureon For Type 2 Diabetes In Japan

Tue, 21 May 2013 00:05:00 PDT

AstraZeneca and Bristol-Myers launched Bydureon subcutaneous injection for the treatment of type 2 diabetes in Japan on May 16.

Eisai President Plans Return To Growth Path With Fycompa, Halaven, Four Others

Mon, 20 May 2013 22:40:01 PDT

With the patents for Alzheimer drug Aricept (donepezil) and proton pump inhibitor Pariet (rabeprazole) expiring later this year, Eisai President Haruo Naito told reporters the company must grow after bottoming out in 2012.

Onglyza Becomes Seventh DPP-4 Inhibitor In Japan

Mon, 20 May 2013 22:05:00 PDT

The manufacture Onglyza (saxagliptin), a DPP-4 inhibitor, was approved in Japan March 25.

How Low Does Merck Need To Go? FDA Safety Concerns May Cut Suvorexant’s Dosing

Mon, 20 May 2013 20:45:01 PDT

FDA will ask an advisory committee whether Merck’s insomnia drug should employ the tiered dosing schedule proposed for the elderly and non-responders, but the agency seems inclined towards a dose even lower that the ones that were used in Phase III.

Elan Tries To Transform With Three New Deals; Wall Street Still Skeptical

Mon, 20 May 2013 18:30:01 PDT

In its continuing effort to spend its way into becoming a diversified pharma, Elan announced a new trio of deals. Some liken its geographically diverse, specialty pharma strategy to that of highly successful Valeant, but Wall Street remains unsure that Elan can execute.

Merger With Warner Chilcott Expected To Turn Actavis Into #3 Specialty Pharma In U.S.

Mon, 20 May 2013 15:20:06 PDT

The rumored combination of Actavis and Warner Chilcott, with Actavis to re-domicile as an Irish firm for tax benefits, came to fruition May 20. Warner Chilcott CEO Boissonneault said the deal resulted from a long friendship with Actavis’ Bisaro and did not come together overnight.

Depo-Provera Black Box Warning Challenged In Physician Petition

Mon, 20 May 2013 15:15:06 PDT

Two obstetrician/gynecologists argue there is no published clinical evidence that extended use of the injectable contraceptive is harmful; they cite a Pfizer-funded study that found Depo-Provera users already had a higher risk of bone fracture than nonusers and the risk did not increase with use of the drug.

Pakistan Transition Government Sets Indefinite Moratorium On Drug Prices

Mon, 20 May 2013 15:15:03 PDT

Pakistan's government in transition has decided to place a moratorium on the price of drugs sold in the country until a new government is able to revise the nation's Drug Price Formula, sources said.

Germany’s G-BA Finds No Added Benefit For CTI’s Pixuvri, Exposing Price

Mon, 20 May 2013 13:55:00 PDT

Germany’s G-BA lets through Cell Therapeutics’ Pixuvri for aggressive B-cell non-Hodgkin's lymphoma but finds no added benefit over existing therapies, meaning its price could come under pressure.

As India Finalizes New Pricing Policy, Analysts Focus On Potential Winners And Losers

Mon, 20 May 2013 11:30:08 PDT

With a new market-based policy in place, prices of leading brands will fall in the short term but losses may be mitigated by tiered pricing and better patient engagement in the long run.

China Pharmas See Foreign JVs, Other Ties As Routes To Global Markets

Sun, 19 May 2013 23:05:03 PDT

Increasingly, China's drug makers such as Zhejian Hisun Pharmaceutical and Simcere are entering joint ventures and other types of partnerships with multinational firms in a two-way dance that suits the growth interests of both parties.

India Health Ministry Said To Do Little To Deal With Foreign-Banned Drugs

Sun, 19 May 2013 23:00:03 PDT

Recent claims by India's health ministry that it was banning drugs also banned in nations with strong regulations, such as Australia, Canada, Japan, the EU, U.K. and U.S., amount to little more than appointing a committee, a parliamentary critic said.

Turkey’s Drug Bill Dips In 2012; Industry Blames Unsustainable Pressure, Government Cites Efficiencies

Sun, 19 May 2013 22:05:01 PDT

Turkey’s spending on drug reimbursement dropped last year as pressure was brought by government price cuts, but manufacturers say the trend is unsustainable. The government says some of the $747 million it saved was because of heightened use of electronic tracking for prescriptions.

South Korea To Launch Global M&A Fund Based On Israel’s Yozma Model

Sun, 19 May 2013 21:10:08 PDT

South Korea’s public fund will help companies expand globally, because private investment is lacking.

Sunshine Act Payment Comparisons Likely Cloudy Due To Disclosure Judgment Calls

Sun, 19 May 2013 21:02:11 PDT

Some answers to industry questions about ambiguity in sunshine regulations may come through enforcement actions, Sidley Austin’s James Stansel says.

Opening A Window: Algeta Must Find Xofigo’s Place In The Prostate Cancer Market

Sun, 19 May 2013 21:02:04 PDT

Bayer/Algeta’s Xofigo was cleared for castration-resistant prostate cancer patients with symptomatic bone metastases, but uptake of the radiotherapeutic will require referrals from most providers to a licensed radiation site and the company must find a way for the drug to be used instead of or in sequence with chemo and other prostate cancer therapies.

Ranbaxy Fraud Settlement Emphasizes Guilty Pleas, Downplays Exclusion

Sun, 19 May 2013 21:01:58 PDT

Although pharmaceutical company settlements in the millions of dollars now seem customary, a guilty plea to seven felonies could signal aggressive government pursuit of manufacturing and data integrity concerns.

Blowing The Whistle On Ranbaxy

Sun, 19 May 2013 21:01:54 PDT

Dinesh Thakur’s “whistleblower” complaint describes his 2004 investigation into the integrity of the data underlying Ranbaxy’s pending and approved drug applications and findings of systemic fraud.

Mixing Business And Philanthropy Yields Returns For Glaxo In Africa

Sun, 19 May 2013 21:01:47 PDT

Ranbaxy’s Troubled Decade

Sun, 19 May 2013 21:01:40 PDT

Almost 10 years ago, the man who would go on to file the “whistleblower” complaint leading to Ranbaxy’s $500 million civil and criminal settlement with the U.S. government went to work for the Indian generic drug maker.

CMS Administrator Tavenner’s Confirmation Reflects Bipartisan Expectations

Sun, 19 May 2013 21:01:37 PDT

Although seven Republican senators voted against Tavenner, many key Republican leaders in the Senate approved, and her nomination to head CMS cleared the chamber 91-7 on May 15.

No Approval, No Pay: VCs Bet Large On Late-Stage Pharma Trials

Sun, 19 May 2013 21:01:34 PDT

Some of the biggest life science VCs are spending hundreds of millions of dollars to run the clinical trials of drugs owned by big drugmakers. But if the strategy works, they may have come up with a better way to diversify their portfolios in an era when long-term company-building isn’t paying off.

Deals Of The Week: Keeping Score – Valeant Wants Actavis, Which Covets Warner Chilcott …

Sun, 19 May 2013 21:01:25 PDT

Meanwhile, companies like Mylan and Novartis also reportedly have joined the Actavis chase. In addition, there’s been deal-making news from Elan and Theravance, Merck-Serono and Quintiles, and AbbVie and Alvine.

Compounding: Can FDA Afford The New Oversight It Wants?

Sun, 19 May 2013 21:00:56 PDT

FDA estimates the compounding user fee proposed in pending legislation would pay for about half the total cost of expanded oversight, but the agency would have to find budget authority dollars to fund significant portions of a new program.