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The Lead

Heat Blamed for FluMist's Failure Against Swine Flu

February 27, 2015 8:25 am | by MIKE STOBBE, AP Medical Writer | News | Comments

The makers of the nasal spray version of the flu vaccine say now they know why it has failed to protect young U.S. children against swine flu — fragile doses got too warm.

Bristol-Myers: Drug Combo Cured Hepatitis C in 97% with HIV

February 27, 2015 8:22 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Bristol-Myers Squibb Co. said Thursday that an experimental combination of two hepatitis C drugs...

Ex-Sanofi CEO Joins PureTech's Board of Directors

February 27, 2015 8:09 am | News | Comments

PureTech, a science and technology R&D company focused  on identifying, inventing and...

Court: J&J Must Pay South Carolina $136M for Deceptive Drug Marketing

February 27, 2015 8:00 am | by MEG KINNARD, Associated Press | News | Comments

South Carolina's high court says a Johnson & Johnson subsidiary should pay the state $136...

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GARDASIL®9 Recommended by CDC’s Advisory Committee on Immunization Practices for Females Aged 9-26 and Males Aged 9-21

February 26, 2015 3:33 pm | News | Comments

Merck has announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to include GARDASIL® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in the recommendations for use of HPV vaccines.

Photo of the Day: Meningitis Vaccine

February 25, 2015 2:19 pm | by Mike Auerbach, Editor-In-Chief | News | Comments

Until recently, there was no vaccine available in the US to help protect against meningococcal group B, one of the most prevalent types of meningococcal meningitis in the US.

FDA Accepts Teva's NDA for Abuse-Deterrent Opioid

February 25, 2015 10:03 am | News | Comments

Teva Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the company’s hydrocodone bitartrate extended-release (ER) tablets formulated with Teva’s proprietary abuse deterrence technology (CEP-33237).

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Study: Pills Before and After Sex Can Help Prevent HIV

February 25, 2015 8:24 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

The study, done in France and Canada, is the first to test "on demand" use of Truvada, a pill combining two AIDS drugs, by people planning to have risky sex. The uninfected men who took it were 86 percent less likely to get HIV compared to men given dummy pills.

Takeda Expands Pharma Operations in Singapore

February 25, 2015 8:14 am | News | Comments

Takeda Pharmaceutical Co., Japan's largest drug company, has expanded its Singapore operations by relocating its emerging markets business unit to the city-state from Zurich, executives said at an inauguration ceremony Wednesday.

GSK's Nonprescription Diet Pill Back in Stores After Recall

February 25, 2015 8:08 am | by The Associated Press | News | Comments

GSK voluntary recalled Alli last March after finding some packages in stores didn't contain real alli, indicating tampering after shipment. The Food and Drug Administration is still investigating.

Watchdog Group Seeks US Ban of Antifungal Tablets

February 24, 2015 11:34 am | News | Comments

A consumer safety group is calling on the U.S Food and Drug Administration to pull certain antifungal tablets off the market, saying there are safer medicines that do not carry risks of liver damage.

FDA Approves Farydak for Treatment of Multiple Myeloma

February 24, 2015 10:14 am | News | Comments

The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.

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Merck Grants Free License for Pediatric HIV Drug

February 24, 2015 8:13 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

Merck has granted a free license allowing one of its HIV medicines to be made and sold inexpensively for use in young children in poor countries hard hit by the AIDS virus.

Shire Acquires Meritage Pharma

February 24, 2015 8:08 am | News | Comments

Shire has acquired Meritage, a privately-held company, for an upfront fee of $70 million and additional contingent payments based on the achievement of development and regulatory milestones.

Jacobs to Design Ireland Biologic Facility for BMS

February 24, 2015 8:03 am | News | Comments

Jacobs Engineering Group has received a contract from Bristol-Myers Squibb Company to provide architectural and engineering services for a new large-scale biologics manufacturing facility in Cruiserath, County Dublin, Ireland.

Baxter Selects Bannockburn, IL, Facility as Location for Baxalta Global Headquarters

February 23, 2015 11:21 am | News | Comments

Baxter International announced today that Baxalta Incorporated, the biopharmaceutical company that is expected to separate from Baxter in mid-2015, will be headquartered in Northern Illinois at 1200 Lakeside Drive, Bannockburn, IL.

Valeant to Buy Salix for Approximately $10B in Cash

February 23, 2015 8:27 am | by ALEX VEIGA, AP Business Writer | News | Comments

Valeant Pharmaceuticals International Inc. has agreed to buy Salix Pharmaceuticals Ltd. for about $10 billion in cash. The companies said Sunday that their boards of directors approved the transaction, which amounts to about $158 for each of Salix's outstanding shares.

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NGM and Merck Announce Agreement to Discover, Develop and Commercialize Novel Biologic Therapeutics

February 23, 2015 8:17 am | News | Comments

NGM Biopharmaceuticals, Inc., a privately-held biotechnology company and Merck announced they have entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas.

Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Sovaldi and Harvoni in India

February 23, 2015 8:13 am | News | Comments

Mylan announced that its Indian subsidiary, Mylan Pharmaceuticals Private Limited, has entered into an agreement with Gilead Sciences, under which Mylan has been appointed as the exclusive distributor of Sovaldi and Harvoni for the treatment of chronic hepatitis C, in India.

Bristol-Myers Squibb to Acquire Flexus Biosciences

February 23, 2015 8:08 am | News | Comments

Bristol-Myers Squibb and Flexus Biosciences announced today the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of Flexus, a privately held biotechnology company focused on the discovery and development of novel anti-cancer therapeutics.

Astellas Creates New Corporate Affairs and Corporate Development Functions

February 20, 2015 8:20 am | News | Comments

Astellas has announced organizational and personnel changes in the Americas, highlighting the company's focus on international markets, while also building new Corporate Affairs and Corporate Development functions.

Sanofi Hires Bayer HealthCare's Brandicourt as New CEO

February 20, 2015 8:12 am | News | Comments

Sanofi said Thursday Brandicourt, 59, will start on April 2. He has been Bayer HealthCare's chairman and CEO since November 2013, and was also an executive for Pfizer Inc.

Merck Ex-Financial Analyst Pleads Guilty in Insider Trading Case

February 20, 2015 8:07 am | News | Comments

Zachary Zwerko pleaded guilty in Manhattan federal court to conspiring to commit securities fraud and three securities fraud counts. A plea agreement recommended a three to four-year prison sentence.

NewLink Announces Clinical Development Milestone Achieved With Merck for Ebola Vaccine Candidate

February 19, 2015 8:51 am | News | Comments

Under the terms of the agreement, NewLink Genetics will receive a payment of $20 million in connection with the achievement of the milestone. The milestone pertains to the initiation of a key clinical trial for the vaccine.

FDA Grants Genentech’s Cobimetinib Priority Review for Use in Combination with Zelboraf in Advanced Melanoma

February 19, 2015 8:18 am | News | Comments

Genentech, a member of the Roche Group, announced the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf ® (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma

Boston Scientific to Pay Johnson & Johnson $600M

February 18, 2015 8:13 am | News | Comments

Boston Scientific will pay $600 million to settle with drugmaker Johnson & Johnson over the medical device maker's $27 billion acquisition of Guidant Corp. in 2006.

Actavis Announces Intention to Adopt "Allergan" Corporate Name

February 18, 2015 8:09 am | News | Comments

The company said that it intends to use the Allergan name as its corporate name and for its global branded pharmaceutical portfolio, and will retain the Actavis name for select geographic regions and product portfolios.

US District Court Decision in PULMICORT RESPULES® Patent Litigation

February 17, 2015 8:44 am | News | Comments

AstraZeneca has announced that the US District Court for the District of New Jersey ruled US Patent No. 7,524,834 (“the ‘834 patent”), protecting PULMICORT RESPULES in the US, is invalid.

GlobalData: Insomnia Treatment Market Faces Steep Decline to 2016, But New Drugs Will Aid Recovery

February 17, 2015 8:39 am | News | Comments

Insomnia drug sales will fall rapidly from $2.1 billion in 2013 to $1.4 billion by 2016, before steadily recovering to $1.8 billion by 2023, driven by the launch of two products, Merck & Co.’s Belsomra and Eisai’s E-2006, and an increase in the prevalent cases of insomnia, says research and consulting firm GlobalData.

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