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Amid Tuesday’s presidential debate, the hearing spoke about the reaction to the coronavirus pandemic and efforts to expand a COVID-19 vaccine In the speech, the president made an un baseless statement that we are weeks away from having vaccines.
It is true that some pharmaceutical corporations are already in a position to produce their COVID-19 candidate vaccines for wider use. This production ensures that the vaccine product is in a position to be distributed upon receipt of a regulatory decision. But corporations are “risking “production because they still don’t know the extent to which their vaccines will work or whether they will be approved. The industry is rejecting, even in private, opposing the indications that such regulatory decisions are imminent. The Associated Press won a memorandum that Pfizer CEO Albert Bourla wrote to employees lamenting the politicization of science.
“I can’t wait exactly when, or even if our vaccine will be approved by the FDA for distribution to the public,” he wrote. “But I know the world will be safer if we avoid talking about vaccine management in political terms. “
Pfizer made more news this week, securing partial rights to a promising cancer drug. This week, some older biotechnology corporations also restructured their organizations, and some new biotechnology corporations raised new funds to expand their projects and advance clinical trials. and many more in this week’s summary.
DRUG DEVELOPMENTS
– A mobile stem treatment that Mesoblast (NASDAQ: MESO) developed to treat graft disease against acute host in young people was rejected through the FDA. According to the corporation, the FDA conducts some other clinical trial in adults and/or young people to provide further evidence of the efficacy of remesemcel-L (Ryoncil).
—Genfit (NASDAQ: GNFT) is cutting its 40 in line with the penny as a component of a business restructuring that will divide the company into two divisions. Adjustments stick to the failure of the company’s flagship drug in a key study on noolic steatohepatitis.
“The FDA lifted the suspension of a clinical trial testing genetic treatment through Solid Biosciences (NASDAQ: SLDB) for Duchenne muscular dystrophy after biotechnology made adjustments to patient exposure to the highest degrees of viruses used to administer mobile treatment.
—The FDA has rejected an oral diazepam (Libervant) formula from Aquestive Therapeutics (NASDAQ: AQST), which was developed as a remedy for attack groups. Boston-based company says the FDA needs more pharmacokinetic data and no new clinical trials are required.
Ironwood Pharmaceuticals drug candidate IW-3718 (NASDAQ: IRWD) failed a Phase 3 review of gastroesophageal reflux disease, leading boston-based company to stop paints on the compound and put into effect a corporate restructuring that will reduce approximately 35% of its production force. .
– Just over a month after the FDA rejected filgotinib, an experimental drug for rheumatoid arthritis from Gilead Sciences (NASDAQ: GILD) and Galapagos (NASDAQ: GLPG), regulators in Europe and Japan approved the tablet once a day.
LET’S MAKE A DEAL.
—Pfizer (NYSE: PFE) is investing $200 million in CStone Pharmaceuticals to secure China’s marketing rights to sugemalimab, the company’s complex cancer immunotherapy.
—The Covis Group agreed to pay $13. 75 according to the consistent percentage to obtain AMAG Pharmaceuticals (NASDAQ: AMAG), a transaction that values the company at approximately $498 million. Earlier this year, AMAG, based in Waltham, Massachusetts, implemented a corporate restructuring that reduced and products sold.
– Bial paid an uns specified amount to obtain Parkinson’s disease systems at the clinical level of Lysosomal Therapeutics. Alongside the agreement, Portuguese company Bial is in the process of creating a Business Unit aimed at Parkinson’s disease in Cambridge, Massachusetts, called Bial Biotech Investments.
—Orgensesis (NASDAQ: ORGS) acquires mobile cure developer Koligo in an inventory market transaction that provides a marketed remedy for acute pancreatitis and a phase 2-ready compound for COVID-19-related respiratory distress.
CASH BIOTECHNICS
Galecto raised $64 million in investment for medium-term clinical trials of 3 drug applicants for 3 other fibrosis bureaucracies.
—Eight months after launching with $ 40 million in investment, Sonoma Biotherapeutics ended its Series A investment cycle with an additional $ 30 million. Preclinical biotechnology develops regulatory T-cell treatments for autoimmune and degenerative diseases.
“Invetx, a start-up that applies the science of biological treatments for humans to the progression of biological drugs for pets and livestock, has expanded its Serie A investment to $25. 5 million as it prepares for pilot studies on its first candidate drug by the end of this year.
—ARCH Venture Partners led $77 million in B-Series funding for Dewpoint Therapeutics, a drug start-up targeting biomolecular condensate. Dewpoint, cambridge, has partnerships with Bayer and Merck (NYSE: MRK).
“Sophia Genetics, a company whose generation is helping healthcare professionals download medical data, has raised $110 million in F-Series investments to expand those offerings in the US. But it’s not the first time And Asia, and to collaborate with biopharmaceutical corporations in the development of new targeted therapies.
– AZTherapies, a drug developer for Alzheimer’s disease, closed its C-Series at $37. 5 million and added another $33. 6 million to AD Series funding. Boston’s leading drug candidate, ALZT-OP1, is in Phase 3 lately.
—Aegle Therapeutics, a biotechnology company founded in Boston and Miami, has raised $6. 5 million in Serie A investment to aid the progression of extracellular vesicles as a remedy for uncommon hereditary skin epidermolysis.
New York’s Imvaq Therapeutics closed a $15 million Serie B investment for his studies on immune-boosting viral treatments for counterfeit tumors.
—Carmot Therapeutics has raised $47 million in C-Series investments for clinical progression of treatments for metabolic disorders, adding type 2 diabetes, obesity and fatty liver disease.
THIS WEEK AT BIOTECH IPOS
—Orphazyme (NASDAQ: ORPH) has raised a total of $83 million by promoting shares in the United States and by promoting more shares in Europe, but updated documents from the Copenhagen-based corporate display that the FDA needs more knowledge about a center threat drug recently under regulatory review for Neimann-Pick Type C disease.
—-C4 Therapeutics raised $182. 4 million in its inventory market debut. Development consistent with protein degradation drugs valued its 9. 6 million offering consistent with percentages of $19 each, exceeding the expected diversity of $16 to $18 consistent with consistent with Watertown percentage, MA These percentages are expected to start trading on the Nasdaq on Friday under the inventory symbol “CCCC”.
—Oncorus, a development consistent with cancer virus treatments, has valued its initial public offering at $15 consistent with a steady percentage in the middle of its target value range, raising approximately $87 million. Nasdaq on Friday under the symbol “ONCR”.
Immunome valued its initial public offering at $12 according to its stake, raising approximately $39 million. Development actions under exton-based antibody therapies, PA, are expected to begin trading on Nasdaq on Friday with the inventory symbol “IMNM”.
—The BIOTECHNOLOGY IPO queue has added Praxis Precision Medicines, Aligos Therapeutics and Tarsus Pharmaceuticals.
R
According to a Reuters report, the FDA is expanding its research on headaches that led to the clinical suspension of testing for a COVID-19 candidate vaccine from AstraZeneca (NYSE: AZN). to analyze it, they told Reuters unidentified resources.
—CureVac (NASDAQ: CVAC) evaluated the first patient in a Phase 2a tested by their MESSENGER RNA candidate COVID-19, CVnCoV. It is expected to recruit 690 participants.
—Moderna (NASDAQ: MRNA) published in the New England Journal of Medicine the intermediate effects of a phase 1 of its COVID-19 vaccine candidate in adults aged 50 to 70 years. Knowledge shows that the mNR vaccine elicited neutralizing antibodies and cellular T-responses.
—Regeneron Pharmaceuticals (NASDAQ: REGN) reported clinical knowledge that it appears that its healing candidate COVID-19, which consists of an antibody cocktail, helped medical visits.
—The FDA discontinued a phase 2/3 that compares an Innovio COVID-19 candidate vaccine (NASDAQ: INO). The Plymouth Meeting, Pennsylvania-based company said the company had questions about the clinical trial plan, and added the device that will deliver the therapy.
PEOPLE ON THE MOVE
Freeline Therapeutics (NASDAQ: FRLN) promoted Romuald Corbau to Chief Scientific Officer . . . José “Pepe” Carmona has been appointed Chief Financial Officer of Rubius Therapeutics (NASDAQ: RUBY) as Chief Financial Officer . . . Nimbus Therapeutics has appointed Abbas Kazimi Chief Commercial Officer . . . Previous Thrive Detection appointed Sam Asgarian Chief Medical Officer and Dina Ciarimboli Chief Legal Officer . . . Invetx appointed Bill Brondyk Chief Scientific Officer and Colin Giles Director of Development . . . Jack Bailey will succeed Mark Velleca as Chief Executive Officer of G1 Therapeutics (NASDAQ: GTHX) . . . Kaleido Biosciences (NASDAQ: KLDO) has appointed Daniel Menichella President and CEO . . . João Siffert, CEO, Director of Research and Development and Medical Director of Abeona Therapeutics (NASDAQ: ABEO), resigned . . . TriSalus Life Sciences has appointed Steven Katz its medical director . . . MiNA Therapeutics has appointed Peter Commercial Director of Bains . . . Ferdinand Massari has joined Deep Genomics as director medicalArr Oh. Prometheus Biosciences recruited O livier Laur ent as Lead Generation Director Array . . Akouos appointed Sachiyo Minegishi as its Chief Financial Officer and promoted Jennifer Wellman to the position of Chief Operating Officer Array . . AZTherapies appointed Marc de Garidel as its Managing Director Array . . Cara Therapeutics (NASDAQ: CARA) has appointed Thomas Reilly its Chief Financial Officer . . . Rupert Sandbrink Joins Vico Therapeutics as Chief Medical Officer . . . Tarveda Therapeutics has appointed Brian Roberts as Chief Executive Officer . . . Adrian Quartel has been Appointed Adamas Pharmaceuticals (NASDAQ: ADMS) Chief Medical Officer . . . Intra-Cellular Therapies has appointed Suresh Durgam as Chief Medical Officer . . . Jennifer Jarrett has joined Arcus Biosciences (NASDAQ: RCUS) as Chief Operating Officer . . . and Roger Perlmutter Retires as Executive Vice President and President of Merck Research LaboratoriesArray
Picture: iStock / Derek Brumby
Frank Vinluan is an editor of Xconomy founded at Research Triangle Park. You can succeed in it at fvinluan@xconomy. com. Follow @frankvinluan
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