News

EMA's revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.

FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.

Facility will use mammalian cell-culture technology and be ready for operations by 2016.

Agreement seeks to advance novel drug targets and focus on therapies for ulcerative colitis.

Acquisition will strengthen AstraZeneca's respiratory portfolio with a potential new treatment for chronic obstructive pulmonary disease.

FDA Discovers Microbial Contamination in Compound Pharmacy Products

Modular containment room at Belfast facility allows studies of biologics and vaccines.

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

A roundup of developments in global health and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Highlights from the 66th World Health Assembly and the pharmaceutical industry?s role in addressing noncommunicable diseases, mental and neurological disorders, R&D for diseases of the developing world, counterfeit medicines, the global vaccine action plan, and neglected tropical diseases.

The agreement is worth up to $552 million, depending on meeting set milestones.

Pfizer had gained the facility through its previous acquisition of King Pharmaceuticals.

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Unither Pharmaceuticals will acquire an UCB Rochester, NY pharmaceutical plant used to liquid pharmaceutical products.

A new panel will create reports that assess changes in the pharmaceutical industry.

The companies cancel plans to develop and manufacture generic drugs in Japan.

With downsizing occurring more frequently than ever within the pharmaceutical industry, is Europe doing enough to curb further job losses that could threaten the recovery of its economy?

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

Competence in process safety is important for preventing accidents.

FDA addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.

Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.

ISTA will pay $33.5 million to resolve criminal liability and false claims allegations.

Amgen and Astellas have entered into a strategic alliance to provide new medicines for serious unmet medical needs of Japanese patients. The alliance leverages the complementary capabilities of both companies through an innovative business model that combines Amgen's pipeline candidates with Astellas' deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading company in Japan.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Johnson & Johnson anticipates submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017; the announcement was made at a recent meeting with industry analysts. Upcoming new products include simeprevir for hepatitis C (already filed in Japan, Europe and the US); ibrutinib and daratumumab for haematologic malignancies; sirukumab and guselkumab for diseases of the immune system such as rheumatoid arthritis and psoriasis; and vaccines for influenza, rabies and polio.

The South Wales, UK contained-manufacturing operation was built in less than a year using design-to-manufacture and modular approaches.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

Valeant Pharmaceuticals and Bausch + Lomb have entered into a definitive agreement under which Valeant will acquire Bausch + Lomb for $8.7 billion in cash.

New design meets new process requirements.