Drug Discovery and Development

Merck KGaA (ETR:MRK) subsidiary MilliporeSigma has opened its second facility in Carlsbad, California, near San Diego. The new $110 million, 140,000-ft² facility more than doubles its production capacity supporting viral gene therapy. The company now has two facilities dedicated to serving customers focused on cell and gene therapy. The facilities can support suspension production of…

Dr. Paul Stoffels, who serves as Johnson & Johnson’s chief scientific officer, will end his tenure on December 31. Stoffels, who is also vice-chairman of J&J’s executive committee, was responsible for reinvigorating J&J’s Janssen pharmaceutical pipeline and was instrumental in developing a COVID-19 vaccine. The company’s CEO and executive chairman, Alex Gorsky, is also retiring…

Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older,…

The gene therapy company Voyager Therapeutics, Inc. (NSDQ: VYGR) has reached an agreement with Pfizer (NYSE:PFE) to license novel capsids from its RNA-driven TRACER screening technology. A capsid refers to the protein shell of a virus protecting its genome. “We believe that our TRACER platform has the ability to produce not only enhanced blood-brain-barrier penetrant…

Messenger RNA (mRNA) therapeutics and vaccines may offer significant promise, but few scientists specialize in the technology. Moderna (NSDQ: MRNA) aims to inspire a new generation of scientists and clinicians to focus on mRNA research with a new fellowship program. The program will support a range of applications within medicine, basic research, epidemiology, pharmacology, nursing…

A former Celgene scientist took the stand on Wednesday in the Elizabeth Holmes federal fraud trial to testify to a partnership the company had with Theranos on certain projects. Victoria Sung testified about speaking to Theranos in 2009 about helping the biopharmaceutical company in a drug trial for a medication in development to treat anemia.…

Moderna (Nasdaq: MRNA) announced today that it will create a 462,000-square-foot Moderna Science Center just a half-mile drive from its present headquarters location in Cambridge, Massachusetts. The creator of messenger RNA (mRNA) therapeutics and vaccines saw its fortunes skyrocket during the COVID-19 pandemic. It successfully created a vaccine against the novel coronavirus that millions have…

Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart. Physicians have traditionally relied on aspirin…

Privately-held Ambys Medicines has announced that it has opened a 52,000-ft² facility dedicated to hepatocyte manufacturing. The facility is certified to current Good Manufacturing Practices (cGMP) regulations. The company, based in South San Francisco, California, also presented data on its novel bioreactor manufacturing at the Joint Congress of the International Xenotransplantation Association, IXA-CTRMS-2021. Focused on…

Rafael Holdings (NYSE:RFL), the parent of Rafael Pharmaceuticals, has announced that Ashok Marin has agreed to join the company’s management team as chief legal officer. Marin will support the company’s quest to become a “fully integrated cancer metabolism therapeutics company,” Rafael Holdings said in a news release. He has previously worked for Gilead, Immunomedics, Mallinckrodt…

Recombinant vector specialist VectorBuilder and Landau Biotechnology, which develops nonhuman primate models for clinical research, have entered into a strategic partnership. The two companies will collaborate on establishing a primate gene therapy R&D center. VectorBuilder is based in Chicago and has facilities in Germany, Japan and China. Landau Biotechnology is headquartered in China. The center…

Boehringer Ingelheim announced today that it acquired Abexxa Biologics, a developer of precision medicines for treating cancer. Acquiring Abexxa, which utilizes a new approach in immuno-oncology and oncology research, offers Boehringer Ingelheim access to the company’s expertise in targeting cancer-specific proteins located inside the cell instead of those expressed on the cell membrane, according to…

Live cell shipping specialist Cellbox Solutions GmbH (Hamburg, Germany) has now formally entered the North American market after setting up an office in Rockville, Maryland. The company is the developer of patented Cellbox technology, a transportable CO2 incubator that hit the European market in 2019. The company has also developed packaging compliant with UN3373 standards…

Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation…

AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer. Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release. Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible…

FDA leaders have issued a statement regarding the agency’s plan for authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release attributed to acting Commissioner…

The National Institutes of Health (NIH) announced a plan to provide approximately $185 million over five years to a consortium researching genomic variation. Initiated and funded by NIH’s National Human Genome Research Institute (NHGRI), the Impact of Genomic Variation on Function (IGVF) consortium will receive the $185 million over five years in the form of…

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug. According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by…

AstraZeneca (LON:AZN) and the European Union have agreed to end litigation related to the supply of its COVID-19 vaccine Vaxzevria (ChAdOx1-S). AstraZeneca had initially contracted with the European Commission to provide 300 million doses of its vaccine with an option for another 100 million, but fell short of its commitment. The level of vaccine doses,…

Caribou Biosciences (NSDQ:CRBU) has announced the publication of data showing that its CRISPR hybrid RNA-DNA (chRDNA) guide technology supports better CRISPR associated protein 9 (Cas9) specificity compared with all-RNA guides. The Berkeley, California–based company’s technology thus enabled accuracy in intended genomic edits in cells while minimizing off-target events.  High Cas9 specificity is useful in the…

Johnson & Johnson (NYSE:JNJ) announced that it is accepting applications for its 2022 Women in STEM2D (WiSTEM2D) Scholars Award. New Brunswick, N.J.–based Johnson & Johnson’s award aims to support assistant or associate academic professors in the disciplines of science, technology, engineering, math, manufacturing and design through three years of mentorship from leaders at the company and…

Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts–based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg…

Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News citing a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within…

Johnson & Johnson (NYSE:JNJ) today announced results from a trial of its HIV vaccine demonstrating a lack of sufficient protection against infection. New Brunswick, N.J.–based Johnson & Johnson’s Imbokodo Phase 2b HIV vaccine clinical trial found that the investigational vaccine regimen did not provide sufficient protection against HIV infection in a 2,600-person population of young…

Signal Rx Pharmaceuticals, Crystec and ADYA are working on a dry powder drug formulation for potentially treating COVID-19-related illness. The three companies’ collaboration for the dry powder formulation of SF2523 covers the treatment of pulmonary fibrosis, lung cancer and illnesses related to SARS-CoV-2, the virus causing COVID-19. Get the full story at our sister site,…