News

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.

CDMO Exothera and biotech company Remedium are joining forces to scale up the manufacturing process for Remedium’s lead gene therapy candidate for treating osteoarthritis.

Takeda plans to build a new facility in Osaka, Japan, for the manufacture of plasma-derived therapies.

Roche and Lilly will collaborate on the development of Roche Diagnostics’ Elecsys Amyloid Plasma Panel.

The Supreme Court heard oral arguments concerning the legitimacy of “genus clauses” in bio/pharma patents.

Narcan, from Emergent Solutions, will be the first naloxone product permitted for use without prescription by FDA.

PharmaBlock has opened a new R&D facility in Pennsylvania, expanding its capacity to deliver GMP projects.

Ingredion has completed two strategic investments in India with Amishi Drugs & Chemicals and Mannitab Pharma Specialties.

Moderna and Generation Bio have announced a strategic collaboration to develop non-viral genetic medicines.

Harm Reduction Therapeutics and Catalent have signed a commercial supply agreement for naloxone nasal spray to reverse opioid overdoses.

Curia is collaborating with Corning to advance biopharmaceutical continuous-flow development and manufacturing programs.

A new Interagency Working Group for Bayh-Dole will review the government’s authority to revoke licenses for medical products.

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Three new awards have been added to the roster for 2023 and include some specific highlights that have occurred over the past few years.

Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

The combined solutions are currently available on the market.

The services are based on the company’s PurePrep EasyClean (PEC) orthogonal peptide purification technology.

The decision was based on results from the PROpel Phase III trial.

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Sanofi intends to cut its US list price for Lantus (insulin glargine injection) by 78% and cap out-of-pocket costs at $35 for all patients with commercial insurance.

BioNTech will receive an exclusive worldwide license from OncoC4 to develop and commercialize its anti-CTLA-4 mAb candidate for solid tumor indications.

Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

Sartorius BIA Separations and Teknova will collaborate to combine their technologies in an effort to streamline the downstream purification process.

Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.

Polyplus’ LipidBrick is designed to expand the scope of lipid nanoparticle formulation usage in mRNA therapeutics and vaccine development.

Stevanato Group will support development and production of pre-fillable syringes for use in Recipharm’s soft mist inhalers.

Evotec and Bristol Myers Squibb have announced progress in their strategic protein degradation partnership.

Predictive Oncology and Cancer Research Horizons have partnered to pursue development of cancer drugs utilizing the PEDAL platform.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.