BioPharma Today

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.

Glaxo’s Tres Cantos Open Lab Trawls For Answers To Neglected Diseases

Sun, 19 May 2013 21:00:19 PDT

Tres Cantos, Spain facility hopes to move molecules into clinical research in 2013/2014. Wellcome Trust has just pledged £5 million to help support the lab’s open R&D programs.

Recent And Upcoming FDA Advisory Committee Meetings

Sun, 19 May 2013 21:00:08 PDT

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Sanofi May Get EU Double Whammy After French Fine For Hindering Entry Of Plavix Generics

Sun, 19 May 2013 21:00:06 PDT

Echoing the European Commission’s probe into whether drug companies blocked regional entry of cheaper generics, France’s Competition Authority has fined Sanofi €40.6 million for hindering domestic access to generic equivalents of its blockbuster clot-buster Plavix.

FDA’s ANDA Approvals

Sun, 19 May 2013 21:00:02 PDT

Generic drug approvals for mid-May.

Emerging Markets Regulatory Tracker: Australia, Brazil, China (Vol. 3 No. 31)

Sun, 19 May 2013 19:05:01 PDT

The Emerging Markets Regulatory Tracker is a periodic PharmAsia News feature that summarizes and links to important regulatory developments impacting the biopharma and medical device industries in the Asia Pacific region and other emerging markets.

India's New Price Controls To Hit 652 Essential Drugs, Cutting Profits

Sun, 19 May 2013 16:10:05 PDT

India's new list of price-regulated essential drugs set to take effect in mid-June will cover 652 bulk drugs and their formulations, with GlaxoSmithKline and Sanofi Aventis to be the most adversely affected.

Report Says Australia's PBS Reached 20-Year Low In Adding New Drugs

Sun, 19 May 2013 16:05:07 PDT

Australia's Pharmaceutical Benefits Scheme has added the lowest number of new drugs to its subsidy list in 20 years, depriving patients of possible savings amounting to nearly $18 billion, according to a report.

Roche Teams With QB3 To Incubate Life-Science Start-Ups In Bay Area

Fri, 17 May 2013 14:40:01 PDT

The pharma and the incubator’s venture arm will provide seed funding for start-ups emerging from their collaborative efforts. Later, Roche may participate in Series A funding or even opt in to buy programs or whole companies.

Patent “Silent Disclaimers” Established Under Rituxan Ruling, Biogen Worries

Fri, 17 May 2013 14:10:01 PDT

Biogen Idec and Genentech petition the Federal Circuit to rehear en banc a ruling that Biogen’s Rituxan patent claim does not cover GlaxoSmithKline’s Arzerra; they say that failing to expressly object to an examiner’s views does not imply they disavowed the scope of a patent claim.

Sprout Pharmaceuticals Inc.

Fri, 17 May 2013 12:55:07 PDT

The backers of Sprout Pharmaceuticals Inc. are convinced the start-up has a drug candidate that can help women who’ve lost interest in sex feel desire again: flibanserin, a daily pill that interacts with receptors in the CNS. It was originally developed by Boehringer Ingelheim, which failed to win FDA approval in 2010 for its use in treating hypoactive sexual desire disorder, but Sprout is optimistic the clinical development work it has since put into the compound will help it win regulators’ approval.

S1 Biopharma Inc.

Fri, 17 May 2013 12:50:07 PDT

Pharmacological intervention for men with sexual dysfunction has become accepted medical practice, but treatment for women has lagged behind. S1 Biopharma Inc. hopes to change that: it was founded with the purpose of identifying and developing solutions for common, untreated sexual dysfunctions that affect women.

Glaxo Uses Contests To Target Young Hopefuls And Academic Minds

Fri, 17 May 2013 12:50:03 PDT

With a view to front-loading GlaxoSmithKline’s pipeline, the drug maker’s venture capital arm SR One is increasingly targeting early prospects – to the point of running intense entrepreneurial competitions to fan the flames of innovation in Europe and tap into early startups there.

Evestra Pharmaceuticals Inc.

Fri, 17 May 2013 12:45:00 PDT

Evestra Pharmaceuticals Inc. aims to leverage its managers’ and advisors’ understanding of steroid drugs, then amplify that with expertise in medicinal chemistry, polymer science, and drug delivery. The company thinks it has the potential to create multiple women’s health products based on vaginal ring devices and new chemical entities that could be potentially safer and more effective than known ones.

Women’s Health: Moving Beyond Gynecology To Sexuality

Fri, 17 May 2013 12:35:04 PDT

Big Pharma’s exodus from women’s health has created opportunities for biotech start-ups, which hope to tap into potentially huge markets. Profiles of Evestra Pharmaceuticals, S1 Biopharma, and Sprout Pharmaceuticals.

Another Ranbaxy Mystery: What Happened To Valsartan?

Fri, 17 May 2013 12:35:00 PDT

Ranbaxy’s valsartan application may have been held back after FDA detected lapses at the company’s new manufacturing site in Mohali, India, according to sources, but the beleaguered company has a plan to move forward.

Russian IP Status: Adequate, But Flawed For Pharma

Fri, 17 May 2013 11:40:00 PDT

In recent years, Russia has adopted IP reforms that bring its patent provisions closer to international standards, but enforcement remains problematic, as are dispute proceedings, in part because there’s a lack of trained judicial experts.

Priming Russia’s Pharma Industry For Innovation

Fri, 17 May 2013 11:35:08 PDT

The Russian government’s aggressive plan to modernize the country’s pharmaceutical industry is stimulating entrepreneurial activities, as well as a flurry of deal activity between local and foreign companies. Many uncertainties remain about the potential opportunities, however, as foreign companies try to sort out changing regulatory and business dynamics.

Europe’s VC Retreat May Threaten Drug Innovation There

Fri, 17 May 2013 11:35:01 PDT

The number of VC firms actively investing in European biotech and life science companies - and the funds available for investing - could fall below the critical mass considered vital for supporting innovation, investors warn.

German State Court Ruling Against Novartis Confirms Legality of HTA For Older Products

Fri, 17 May 2013 11:00:00 PDT

A State Social Court of Berlin-Brandenburg ruling against Novartis means that Germany's reimbursement bodies can move forward with the benefit assessment of older pharmaceutical products.

Hanwha Biologics CEO Paul Coleman On Developing Biosimilars In Korea: An Interview With PharmAsia News (Part 2 of 2)

Fri, 17 May 2013 09:15:00 PDT

The former Biogen Idec exec sits down to talk about Hanwha’s biosimilars strategy and pipeline, and why its deal fell apart with Merck to develop a biosimilar of Enbrel.

GSK Price Cuts Fuel Growth In Emerging Markets

Fri, 17 May 2013 05:50:01 PDT

GlaxoSmithKline has been growing in emerging markets on the back of price cuts that drive volume and market access.

New EDL To Intensify Competition In China

Thu, 16 May 2013 23:10:01 PDT

The new national essential drug list will likely trigger industry consolidation, diverse strategies, and rigorous marketing.

China’s NDRC Considers EDL Drug Price Cuts

Thu, 16 May 2013 22:35:00 PDT

China’s National Development and Reform Commission is considering adjusting essential drug prices.

Ambit IPO Ambles Out; Portola And Bluebird Prepare

Thu, 16 May 2013 20:50:01 PDT

Despite pricing well below its range and trading down, Ambit could raise $90 million in an IPO and a private placement with existing investors. Also this week, gene therapy company bluebird bio filed for an IPO, and hematology play Portola made the rounds on its investor road show.

RuiYi Signs On New Partners To Develop Anti-IL6 mAb In China

Thu, 16 May 2013 19:10:01 PDT

The China-U.S. hybrid signs on Shanghai-based Genor Biopharma in a co-development deal and contract manufacturer CMC Biologics to develop a cell line for RYI-008 for global manufacturing.

Malaysia Drug Regulators See Harmonization As Long-term Plus For Domestic Industry

Thu, 16 May 2013 18:50:01 PDT

Malaysia’s National Pharmaceutical Control Board sees harmonization as opening doors for investment and local manufacturers to gain markets regionally and abroad.

FDA Approves Simponi For Ulcerative Colitis

Thu, 16 May 2013 16:10:13 PDT

J&J received approval to market a second TNF inhibitor to treat the bowel disorder. The authorization comes as Simponi’s increasing sales point toward blockbuster status.

Whistleblower Found Fraud Endemic At Ranbaxy For More Than Decade

Thu, 16 May 2013 16:10:10 PDT

The fraud activities recently acknowledged by Ranbaxy Laboratories apparently were deep-seated in the company's operations for more than a decade, according to an in-depth report featuring the whistleblower who exposed the activity.

NICE Lets Astellas Pharma’s Betmiga Pass, But On A Restricted Indication

Thu, 16 May 2013 16:05:00 PDT

NICE gives the nod to Astellas Pharma’s Betmiga for overactive bladder control due to its cost-effectiveness but nevertheless restricts its indication because it’s not superior to existing therapies.

India Institutes New Pricing System For Essential Drugs

Thu, 16 May 2013 16:00:06 PDT

India's new system of controlling the prices of essential life-saving drugs sold in the country has taken effect, replacing the prices control system it had used since 1995.

Japan Health Ministry Orders Probe Of HPV Vaccine Side Effects

Thu, 16 May 2013 15:55:02 PDT

Japan health authorities have issued a caution to physicians to be alert for side effects of cervical-cancer vaccines after a citizens group complained of unusually high numbers of problems.

Large Compounders’ Reporting Requirements Would Move Closer To Manufacturers’ In Senate Bill

Thu, 16 May 2013 15:30:00 PDT

Compounding manufacturers would have to report adverse events and quality problems much like traditional drug and biologic makers as a Senate committee moves toward mark up of legislation.

Lilly Bracing For Possible Medicare Non-Coverage Or CED Decision On Amyvid

Thu, 16 May 2013 15:20:01 PDT

Lilly executives discuss likely outcomes of a pending CMS draft decision on Medicare coverage for the beta amyloid imaging agent Amyvid, emphasizing that a decision for non-coverage or coverage with evidence development would be a major setback for research and development in Alzheimer’s disease.

New Nimodipine Formulation Aimed At Reducing Fatal Medication Errors

Thu, 16 May 2013 14:25:01 PDT

Nymalize, an oral formulation of brain hemorrhage treatment nimodipine, aims to minimize serious risks associated with incorrect administration of older forms of the drug.

Korea Suspends Production Of 5 Janssen Products

Thu, 16 May 2013 12:10:00 PDT

Ending a two-week investigation into GMP deviations of J&J’s Korean unit, the Ministry of Food and Drug Safety orders a halt on manufacturing of five products.

Another Ranbaxy Mystery: What Happened To Valsartan?

Thu, 16 May 2013 11:40:07 PDT

Novo Struggles In Japan, Sanofi Struggles With Distributors: Emerging Markets Earnings Roundup (Part 7)

Thu, 16 May 2013 10:30:10 PDT

Both Novo Nordisk and Sanofi had a bumpy start of the year in Asia and emerging markets. Novo saw insulin sales decline in Japan and Korea, while Sanofi grew only 6.5% in emerging markets, well below the company’s long-term guidance of double-digit growth.

Most New Patients In Japan Take DPP-4 Inhibitor As First Choice

Thu, 16 May 2013 02:45:01 PDT

More than 50% of patients with type 2 diabetes in Japan are prescribed a DPP-4 inhibitor, according to a JMIRI survey on prescribed oral hypoglycemic agents.

U.S. Group Wants India Removed From Import-Preference List Over CL Use

Thu, 16 May 2013 01:35:03 PDT

A group is urging removal of India from the U.S. Generalized System of Preferences program of beneficial import treatment, citing regulations that harm competitors, including those in the pharmaceutical industry.

Cipla Medpro Stockholders Agree To $488 Million Buyout By India Creator

Thu, 16 May 2013 01:30:00 PDT

South Africa's Cipla Medpro has agreed to a $488 million acquisition from Cipla, the India firm that helped create it as a source for its drug supplies.

Amgen, Novartis Are Investors In Atlas Venture’s Ninth Fund

Wed, 15 May 2013 21:05:00 PDT

Atlas pledges to explore areas of mutual interest to the firm and its new corporate limited partners, but the drug firms won’t receive exclusive rights to anything in the new fund’s portfolio.

House Track-And-Trace Bill Moves Out Of Committee But No Closer To Senate On Unit-Level Tracing

Wed, 15 May 2013 17:20:01 PDT

Energy and Commerce Committee rejects Rep. Pallone’s amendment to mandate an implementation date for unit-level tracking.

Amgen-Beta JV Significant For China Medical Industry, Execs Say

Wed, 15 May 2013 16:10:03 PDT

Amgen-Beta Pharma, the joint venture formed recently by Beta Pharma and Amgen is far more ambitious than its initial focus on getting Vectibix (panitumumab) for colon cancer on China's market, company officials said.

PT Indofarma, Europe Partner To Produce Albumin In Indonesia

Wed, 15 May 2013 15:55:02 PDT

Indonesia's state-owned PT Indofarma said it plans to have its own albumin drug for local consumption in 2014 to end the nation's reliance on imports and serve the nation's own increasing need.

Broader Indications For Tarceva As Astellas Scales Back In The U.S.

Wed, 15 May 2013 14:45:00 PDT

The Japanese pharma is consolidating its U.S. operations, including the shuttering of OSI, where Tarceva initially was developed, as the cancer drug gains another indication with a companion diagnostic.

Bayer/Algeta’s Xofigo Brings New Mechanism To Prostate Cancer Field

Wed, 15 May 2013 14:30:01 PDT

FDA approved the first alpha particle-emitting radioactive therapeutic agent, Bayer/Algeta’s Xofigo (radium Ra 223 dichloride), for prostate cancer patients with symptomatic bone metastases, three months ahead of the expected PDUFA date.

Part D Preferred Pharmacy Networks Need More CMS Oversight, Senators Say

Wed, 15 May 2013 14:05:00 PDT

The bipartisan group of senators asks the agency to detail steps designed to ensure that Part D plans with preferred networks are not increasing costs to Medicare or impeding beneficiary access to drugs.

As New Biosimilars Roll Out, Indian Biotech Group Raises Quality Concerns

Wed, 15 May 2013 11:00:01 PDT

Leading biotech group ABLE cautioned the government that India should not become a dumping ground for low-quality biosimilar products. The group pointed at several concerns related to Cipla’s latest launch of Enbrel copies.

Hanwha Biologics CEO Paul Coleman On Developing Biosimilars In Korea: An Interview With PharmAsia News (Part 1 of 2)

Wed, 15 May 2013 10:05:13 PDT

The former Biogen Idec exec sits down to talk about Hanwha’s biosimilars strategy and pipeline, and why its deal fell apart with Merck to develop a biosimilar of Enbrel.

Biosimilar Remicade Will Pit Rising Cost Pressures Against Prescriber Caution

Wed, 15 May 2013 10:05:00 PDT

If approved in Europe this year, as expected, Celltrion/Hospira’s biosimilar infliximab will provide a compelling test of whether and how quickly budgetary pressures can override physician caution. It will also set the stage for the $70 billion worth of copycat antibodies in development.

PhRMA Pushes Cost Savings Of Novel Drugs In Japan, Just As New Prices Announced

Wed, 15 May 2013 07:10:01 PDT

Celgene CEO Robert Hugin outlined cost effectiveness of new drugs and met with Japan’s prime minister in his first overseas trip as the new chairman of PhRMA.

Celltrion Sale Problems Said Due To Trust In Company, Sources Say

Tue, 14 May 2013 23:00:04 PDT

Celltrion founder Seo Jung-jin recently offered for sale his controlling stake in an effort to prevent stock market manipulation of his attempt to sell it, but that has not saved a dive in its perceived value.

Toyama Licenses Cempra's Solithromycin Antibiotic For Japan Market

Tue, 14 May 2013 22:55:01 PDT

Toyama Chemical has licensed Cempra's solithromycin antibiotic for treating pneumonia and expects to begin clinical trials in Japan with a goal of applying for marketing approval within the next five years.

FDA’s Potential Black Hole: House Investigates Departure Of Acting Head Of Medical Products Office

Tue, 14 May 2013 20:20:01 PDT

Energy and Commerce Committee letter states public information discrepancies raised questions about Leona Brenner-Gati’s status and “the circumstances surrounding her resignation.”

HIV Drug Development Challenge: Will Patients Accept Risk Of Cure?

Tue, 14 May 2013 19:45:00 PDT

The second of FDA’s 20 patient-focused drug development meetings will tackle barriers to patient enrollment in HIV cure studies and current gaps in HIV therapy.

J&J Hoping To Position Simeprevir As Top Next-Gen Protease Inhibitor For HCV

Tue, 14 May 2013 19:05:00 PDT

The pharma’s Janssen Research & Development unit has filed protease inhibitor simeprevir for approval in the U.S., Europe and Japan, recently receiving notification of priority review from FDA; meanwhile, the company waits to see if its compound will be used in combination with Bristol’s daclatasvir or Gilead’s sofosbuvir.

Jiangxi To Cut Prices Of 37 Drugs

Tue, 14 May 2013 17:15:02 PDT

The Jiangsu Development and Reform Commission will slash the prices of 37 pharma products May 15.

China To Launch EDL Policies In May; Tender Requests Before 2014

Tue, 14 May 2013 17:10:00 PDT

Chinese authorities plan to launch relevant policies surrounding the national Essential Drug List from May to August.

Flu-Stricken Guangdong Lifts Tamiflu Use Restrictions In Hospitals

Tue, 14 May 2013 17:00:05 PDT

Guangdong’s health bureau released guidance for neuraminidase inhibitors such as Tamiflu for clinical use in health institutes as peak flu season picks up speed.

Hunan To Trial Publicizing Blacklisted Pharma Practitioners

Tue, 14 May 2013 16:55:04 PDT

Hunan FDA will publicize blacklisted pharma on its Website for two years under its recently launched drug safety guidelines, keeping a public archive.

Daiichi Sankyo To Send More Personnel To Improve Ranbaxy Quality

Tue, 14 May 2013 16:05:00 PDT

Daiichi Sankyo plans to pour more of its personnel into India to help beef up quality control at its Ranbaxy Laboratories unit and get two of its plants back exporting generic drugs to the U.S. sooner than the original 2017 date.

Biohit Oyj Targets East Asia-Prevalent Form Of Stomach Cancer

Tue, 14 May 2013 15:50:00 PDT

Finland drug maker Biohit Oyj is eyeing China's drug market for what CEO Semi Korpela says could be a good fit for its Acetium (l-cysteine) treatment for a genetic form of stomach cancer prevalent in Asia.

Alvine Hopes To Bring The First Celiac Drug To Market With New Partner AbbVie

Tue, 14 May 2013 15:05:01 PDT

Alvine and AbbVie have inked a deal that could allow the larger company to acquire the biotech based on results of a Phase IIb trial for its celiac disease treatment.

Merck KGaA Updates 2013 Guidance With 2014’s Targets

Tue, 14 May 2013 13:25:00 PDT

Quicker than expected cost-savings from its efficiency program improved the family-owned company’s overall financial outlook, but sales of best-selling product Rebif are still expected to decline in the second half of 2013 following launch of competing oral MS drugs.