News

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Innate Pharma announces a co-development and commercialization agreement with AstraZeneca to accelerate the development of Innate’s anti-NKG2A antibody.

The agency has recommended granting marketing authorization for Opdivo.

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

MaxCyte announces a strategic partnership with Johns Hopkins University to develop CAR T-Cell therapies for cancer.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

The European Medicines Agency releases findings from marketing authorization application analysis.

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

The acquisition expands Sartorius Stedim Biotech’s service portfolio.

FDA approved the first generic version of Copaxone (glatiramer acetate), a widely prescribed drug to treat multiple sclerosis. The generic version of the medication, called Glatopa, will be marketed by Sandoz and Momenta. Glatopa is the first generic indicated for the treatment of patients with relapsing-remitting forms of multiple sclerosis (RRMS).

The new center will primarily support SAFC’s biopharmaceutical development and manufacturing clients in Asia.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The company announced that a pharmacokinetic study comparing ONS-1045 to US- and EU-sourced Avastin will conclude shortly.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Spending on prescription medications reached $373.9 billion in 2014, representing the largest increase in 13 years.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Hydra Biosciences enters into an agreement with Boehringer Ingelheim to research and develop small-molecule TRP inhibitors for renal diseases and disorders.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

The grants will be offered to investigators conducting research in the field of PCSK9 biology.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

FDA issues a Warning Letter to Hospira S.p.A. for GMP violations at the company’s Liscate, Italy facility.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.