News

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.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

The companies will use Ajinomoto’s AJICAP proprietary site-specific bioconjugation technology for the development of Bright Peak’s Immunocytokines.

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.

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

The companies will work together to determine the impact on autologous and allogeneic cell therapies by combining Kytopen’s proprietary Flowfect technology for non-viral cell engineering with other steps in the manufacturing process.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

Mikael Hagstroem has been named as the company’s new CEO.

The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

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.

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business.

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

Nordic Capital has invested in medical dermatology company, Leo Pharma, becoming an active minority owner and partner to the Leo Foundation.

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

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.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

Cybin will use Catalent’s Zydis orally disintegrating tablet technology for the delivery of its novel deuterated tryptamine, CYB003, a potential therapy for treatment-resistant psychiatric disorders.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

The companies will work to discover and develop RNA-targeting small-molecule therapeutics for difficult-to-address indications.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

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

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.