
FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

Norbrook Laboratories will be showcasing its portfolio of APIs and its range of Norbrook Finished Product at CPhI Worldwide 2014.

CPhI released Part 1 of its annual industry report focused on innovation in the market.

CPhI Worldwide 2014 brings new technology and expansions from Catalent.

Patheon will showcase its biologic, small molecule API development services, and manufacturing capabilities for finished dosage forms at CPhI/ICSE Worldwide.

New rules from the Treasury Department regarding inversion affect merger activity in the pharmaceutical sector.

The total market for biopharmaceuticals in 2013 was $36.8 billion according to Kalorama Information. Meanwhile, Frost & Sullivan estimates that the biosimilars market, which it pegged at just $1.2 billion in 2013, will grow to $23 billion in 2019, or more than 20-fold increase.

While advances in chemocatalysis for chiral synthesis continue apace, many companies have focused attention on the development of a wider array of enzymes that can be used under commercial manufacturing conditions for the selective conversion of various substrates into more complex intermediates.

Sigma-Aldrich has reached an acquisition agreement with Cell Marque to further their antibody portfolio.

Pharmaceutical Technology Europe spoke with Piero Iamartino, R&D director at Micro-Macinazione, about the role of micronization in pharmaceutical manufacturing.

The last 12 months have seen a number of major acquisitions in the contract manufacturing space.

Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.

Delivery of large protein biopharmaceuticals may now be administered orally with the help of microneedles, according to researchers at MIT.

Capsugel has received EXCiPACT certification for its sites in Bornem, Belgium, and Colmar, France.

Consort Medical announced that it has agreed terms to acquire the entire issued and to be issued share capital of Aesica Pharmaceuticals for £230 million.

LABOCHIM SpA completes construction on multipurpose high-potent API plant in Milan.

CPhI Worldwide releases "25 pharma stories made at CPhI" for 25th anniversary.

Dow Corning will present new silicones for topical ingredients, topical excipients, transdermal adhesives, and oral APIs at booth 5R31.

Lucideon announced that it is investing £1.5 million to expand its headquarters to include pharmaceutical quality-control testing laboratories.

Manufacturing drugs from biological sources sometimes can't be rushed, even when a rare disease becomes more widespread.

The recovery of an occasional mold does not merit any particular concern. On the other hand, evidence of mold proliferation indicative of infection of facilities or equipment must be taken seriously and requires the prompt implementation of corrective and preventive actions.

AAPS supports graduate-level programs impacted by cutbacks in funding and resources.

West Pharmaceutical Services announced that they will form a new facility in Ireland for the production of insulin injector cartridge packaging components.

Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

Baxter International announced it will form a R&D center in Cambridge, Massachusetts for its new biopharmaceutical company, Baxalta.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

AMAG Pharmaceuticals announced the acquisition of women?s health brand, Lumara Health, for $675 million, with an additional contingency of up to $350 million.

Johnson & Johnson announced the acquisition of Alios BioPharma to expand their portfolio of therapeutics for viral infections.

A new Thomson Reuters BioWorld report outlines the more than 700 biosimilars that are currently in development and the emerging business opportunities that exist in the biopharmaceutical space.

SCHOTT will present the adaptiQ ready-to-use vials, syriQ prefilled syringes, and the TopPac Polymer syringes at CPhI Worldwide 2014 in Paris.