News

FDA has released a list of more than 50 guidance documents planned for 2013.

Shire announced that it has reached an agreement in principle with the US government to resolve the previously disclosed civil investigation into its sales and marketing practices in the US relating to the company?s attention deficit hyperactivity disorder (ADHD) drugs, Adderall XR and Vyvanse as well as the ADHD patch Daytrana.

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a CRO based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialization of the product.

Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

Following its recent acquisition, Actavis (formerly Watson Pharmaceuticals) unveiled its long-term growth strategy during its investor meeting in New York.

FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved FluBlok for people 18–49 years old.

Rutgers engineers constructed a direct compaction line in collaboration with Janssen.

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.

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

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.