Industry News

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production, in expanded emergency production capacity and enhanced US infrastructure for biopreparedness, and in greater production onshore of APIs.

BIA and Clarivate have released data showing that UK biotech companies are set to experience another strong year for fundraising in 2021.

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.

The EC has approved Roche's treatment for 5q spinal muscular atrophy (SMA), Evrysdi (risdiplam).

UK's Ofwat and Nesta Challenges have called on pharmaceutical innovators to collaborate with water companies for the new Water Breakthrough Challenge.

NICE has recommended carfilzomib in combination with lenalidomide and dexamethasone (KRd) as a treatment for adult patients with multiple myeloma who have already had one previous therapy.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

The Janssen Pharmaceutical Companies of Johnson & Johnson revealed that EMA's CHMP has issued a positive opinion for Ponvory (ponesimod) for the treatment of RMS.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices.

The company is recalling the product because of crystallization in vials.

The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

ABPI has responded to the publication of the UK government’s plans for the future of clinical research.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out?

The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

CPhI’s post-pandemic report predicts strong progression in pharma innovation, with breakthroughs in multi-modal disease therapies, a transformative effect of mRNA platforms, and significant growth in contract services.

MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.

BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

The Federal Trade Commission is launching a broad review of drug-company mergers, with an eye to examining how such actions can harm competition in the biopharmaceutical industry.

With no final nomination of FDA commissioner coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).