News

FDA’s annual manufacturing report card shows more quality compliance is needed.

Big Pharma is partnering with Alphabet company, Verily, to modernize clinical trials and accelerate time-to-market for drugs.

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

Cannuba has announced that it is collaborating with an independent scientific body on drugs from the UK on the launch of a medical cannabis working group.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

ABPI has issued a response to the recent publication of the UK's Migration Advisory Committee’s full review on the shortage occupation list.

Metrohm gains B&W Tek’s line of spectroscopy instruments as well as expertise and facilities.

Knauer has introduced new columns and screening services for the enantioseparation of chiral substances.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

As part of its work to combat the opioid crisis, the agency is considering fixed-quantity, unit-of-use blister packaging for certain immediate-release opioid analgesics.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.

Eli Lilly is set to acquire exclusive worldwide rights for potential non-opioid treatment CNTX-0290 from Centrexion Therapeutics in a deal potentially worth $997.5 million.

The company says it will work with payers to create payment options for its recently approved gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), priced at $2.125 million.

Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.

The agency says Novartis drug is the first PI3K inhibitor to be approved for treating breast cancer.

By connecting manufacturing processes and logistics technology, GE Healthcare and World Courier look to accelerate the development of advanced therapies.

Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.

A new partnership is aiming to advance the use of sublingual delivery technology for challenging drugs.

The agency has approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy to treat pediatric spinal muscular atrophy.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Cegedim, has announced that it is collaborating with Sanofi to deliver real-world data for the improvement of health within Europe.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Medherant has announced that it is the recipient of a new £2-million (US$2.5-million) investment from Mercia Technologies.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.