Top News

Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.

The companies will split Actellion’s drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.

A new FDA Q&A document released on Jan. 12, 2016 describes 180-day exclusivity for generic-drug manufacturers and explains the number of conditions under which an abbreviated new drug applicant (ANDA) submitting a paragraph IV certification would forfeit eligibility to be the authorized generic manufacturer of a drug.

FDA released a long-awaited draft guidance to help sponsors seeking to demonstrate interchangeability for biosimilar products.

Industry experts identify the future focus of the biopharma industry in a new survey.

FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.

J&J’s Innovation Global announced the company has entered into 15 new collaborations.

Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.

The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

Shire plans to establish a 550,000-square-foot campus that will focus on innovation in rare diseases and highly specialized conditions.

What’s ahead for the healthcare and pharmaceutical industries?

Teva and IBM expanded their partnership to focus on drug development and chronic disease management.

BASF announced that steamcrackers are slowly being restarted at the company’s plant in Ludwigshafen.

A UK appeals court ruled against Pfizer, saying generic-drug makers did not infringe on Lyrica’s pain patent.

Mylan reached a $485-million settlement with the Department of Justice over questioned raised about the Medicaid rebate classification of EpiPen.

Pfizer announced its decision to remain one company after debating the possibility of splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

Walmsley will succeed Andrew Witty as CEO of the British drug maker.

On Sept. 19, 2016, FDA announced that it has granted accelerated approval to Exondys 51 (eteplirsen), an injection for the treatment of Duchenne muscular dystrophy (DMD). The drug is marketed by Sarepta Therapeutics in the United States and is currently the only approved treatment for DMD. In light of the approval, Sarepta shares catapulted 76%, Seeking Alpha reported.

The department gave Moderna $8.2 million to accelerate development of an mRNA-based Zika vaccine.

The company will launch a generic version of EpiPen at the price of $300 for a two-pack.

The initiative targets countries with less developed and evolving healthcare systems such as Latin America, South East Asia, and Africa.

Ranking members of the Senate Judiciary Committee called on Mylan to explain its decision to raise the price of EpiPens nearly 400%.

The portfolio in this agreement include approved antibiotics Merrem, Zinforo, and Zavicefta, as well as candidates in clinical development, ATM-AVI and CXL.

Pfizer will acquire Medivation for approximately $14 billion.

The legal battle between the Broad institute and UC Berkeley heated up after an email was released from a former graduate student.