News

Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland.

The European Medicines Agency has revised its guideline for the evaluation of anticancer medicinal products.

Eli Lilly expects overall revenue growth in the coming year.

Shire has signed an agreement to acquire Lotus Tissue Repair, Inc., a biotechnology company developing the first and only protein replacement therapy for the orphan disease, dystrophic epidermolysis bullosa (DEB).

Janssen Pharmaceuticals, Inc. and GlycoVaxyn AG have entered into a three-year agreement to collaborate on the research and development of a multivalent bacterial vaccine utilizing GlycoVaxyn's bio-conjugation technology.

AbbVie, a research-focused, specialty biopharmaceutical company that was spun off from Abbott Pharmaceuticals, was officially launched on Jan. 2, 2013.

The PATH Malaria Vaccine Initiative and Inovio Pharmaceuticals have announced a follow-on collaboration to advance the development of malaria vaccines and new vaccine delivery technologies.

Additional approvals in December have helped to outpace a recent high set in 2011.

Amgen has agreed to pay $762 million to resolve criminal liability and false claims act allegations.

Mylan Inc. has issued a recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that these lots (lots 3037841, 3040859 and 3042573) may exceed the potency stated on the label.

Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.

GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Amgen has agreed to pay a settlement of $762 million to resolve federal litigation accusing the company of inappropriately marketing the anemia treatment, Aranesp, for unapproved uses.

AIMM Therapeutics and Cosmo Pharmaceuticals have entered into a strategic partnership to develop oral diagnostic and therapeutic antibodies for gastrointestinal diseases including colon carcinoma.

Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.

BASF has extended its offer period to acquire all of the issued and outstanding shares of Pronova BioPharma.

Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialise in vaccines and antibodies.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Pfizer has agreed to pay $55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October, 2009) improperly promoted the drug Protonix (pantoprazole).

The US Supreme Court accepted an appeal by the Federal Trade Commission of a decision that upheld an arrangement of payments by Solvay Pharmaceuticals to generic drug companies to postpone introduction of generic versions of its branded testosterone-replacement drug.

Biogen Idec and Isis Pharmaceuticals announced that they have entered into a global collaboration agreement under which the companies will discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

Eli Lilly released its annual report containing updates on progress and new initiatives in corporate responsibility.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

GlaxoSmithKline announced its intent to increase ownership in its publicly-listed, consumer-healthcare subsidiary in India and in GlaxoSmithKline Consumer Nigeria as part of its emerging-markets investment strategy.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.