Caroline Hroncich

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

Analytical products for improved bio/pharmaceutical development.

Teva said it plans to appeal a district court decision that invalidated several of the company’s Copaxone patents.

The medical cannabis producer has become compliant with EMA’s GMP standards.

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.

The company agreed to pay Forward Pharma $1.25 billion to settle a patent dispute over the formulation of Tecfidera, the company’s leading multiple sclerosis treatment.

An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

A study of 53 cancer drugs found that new treatments extended patient life an average of 3.43 months when compared with treatments available in 2003.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

Kaléo announced on Oct. 26, 2016 that the company will reintroduce the AUVI-Q (epinephrine injection) to the United States market during the first half of 2017. AUVI-Q is a prescription epinephrine autoinjector used to treat anaphylaxis. The autoinjector includes an automatically retractable needle and a voice prompt system that guides the user through delivery.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

A new study proposes a new way to potentially treat congenital diseases in utero.

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.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

Researchers from the Wyss Institute explain a potential method for transporting and producing temperature-sensitive pharmaceuticals at a reduced cost.

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.

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.

Results show the drug was effective at reducing the risk of uveitic flare or visual impairment.

Industry experts discuss recent trends in modular manufacturing.

Results from a small Phase Ib trial with Biogen’s aducanumab showed the drugs potential as an investigational treatment for patients with Alzheimer’s disease (AD). Researchers from the University of Zurich evaluated the efficacy of aducanumab in 165 patients with early-stage AD. At the conclusion of 54 weeks, the researchers reported seeing a dose-dependent reduction of amyloid-beta in patient’s brains compared to a placebo. Exploratory results indicate the drug may also slow clinical decline.

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

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

A new study reveals a potential new approach to treat sickle cell disease and beta thalassemia using CRISPR-Cas9 gene-editing technology.

FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.

The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.