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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. Industry opposes, even in private, advice 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. stories and more in this week’s news summary.
DRUG DEVELOPMENTS
– The FDA rejected a mobile stem treatment that Mesoblast (NASDAQ: MESO) developed to treat acute graft-versus-host disease in young people. young people in order to provide further evidence of the efficacy of remestemcel-L (Ryoncil).
—Genfit (NASDAQ: GNFT) is cutting its 40 in line with the penny as a component of a corporate 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 levels of viruses used to administer mobile treatment.
—The FDA rejected an oral film of Aquestive Therapeutics (NASDAQ: AQST) formulas of diazepam (Libervant), which was developed as a remedy for seizure groups. Boston-based company says FDA needs more pharmacokinetic data and no new clinical trials are underway.
Ironwood Pharmaceuticals (NASDAQ: IRWD) drug candidate IW-3718 failed a Phase 3 examination on gastroesophageal reflux disease, prompting the 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 two hundred million dollars 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 clinical-level Parkinson’s disease systems from Lysosomal Therapeutics. Along with the agreement, The Portuguese company Bial is in the process of 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 supplies a marketed remedy for acute pancreatitis and a ready-to-phase 2 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 its launch with $40 million in investment, Sonoma Biotherapeutics ended its Serie A investment cycle with another $30 million. Prec lithuanian biotechnology develops T-cell regulatory treatments for autoimmune and degenerative diseases.
“Invetx, a start-up that applies the science of human biological treatments 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 financing for Dewpoint Therapeutics, a startup that develops that target biomolecular condensate. Dewpoint, based in 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 the investment for the “C-1” series. 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 a Serie A investment to aid the progression of extracellular vesicles as a remedy for hereditary epidermolysis of rare skin bubbles.
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 through promoting stocks in the United States and by promoting more stocks in Europe, but updated documents from the Copenhagen-based corporate exhibition that the FDA needs more knowledge on an imaginable threat drug from the center recently under regulatory review for Type C Neimann-Pick 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 IPO 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 testing his candidate for COVID-19 messenger RNA vaccine, CVnCoV. It is expected to recruit 690 participants.
—Moderna (NASDAQ: MRNA) published the interim effects of a phase 1 of its COVID-19 vaccine candidate in adults ages 50 to 70 in the New England Journal of Medicine. Knowledge shows that the mRNA vaccine elicited neutralizing antibodies and mobile 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 has suspended 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 therapy.
PEOPLE ON THE MOVE
Freeline Therapeutics (NASDAQ: FRLN) has promoted Romuald Corbau to Chief Scientific Officer . . . Jose “Pepe” Carmona has been appointed Chief Financial Officer of Rubius Therapeutics (NASDAQ: RUBY) as Chief Financial Officer . . . Nimbus Therapeutics has appointed Abbas Kazimi Director Commercial . . . 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 Chief Development Officer . . . Jack Bailey to succeed Mark Velleca as CEO of G1 Therapeutics (NASDAQ: GTHX) . . . Kaleido Biosciences (NASDAQ: KLDO) appointed Daniel Menichella President and CEO . . . João Siffert, CEO, Director of Research and Development and Chief Medical Officer of Abeona Therapeutics (NASDAQ: ABEO), has resigned . . . TriSalus Life Sciences has appointed Steven Katz as Medical Director . . . MiNA Therapeutics has appointed Peter Commercial Director of Bains . . . Ferdinand Massari has joined Deep Genomics as Medical Director icalArray . . Prometheus Biosciences has O livier Lauren t as CTOArray . . Akouos appointed Sachiyo Minegishi as CFO and promoted Jennifer Wellman to COOArray . . AZTherapies appointed Marc de Garidel as CEO Array . . Cara Therapeutics (NASDAQ: CARA) appointed Thomas Reilly its CFO . . . Rupert Sandbrink Joins Vico Therapeutics as Chief Medical Officer . . . Tarveda Therapeutics has appointed Brian Roberts as its Chief Executive Officer . . . Adrian Quartel has been appointed Chief Medical Officer of Adamas Pharmaceuticals (NASDAQ: ADMS) . . . Intra -Cellular Therapies has appointed Suresh Durgam as its Chief Medical Officer . . . Jennifer Jarrett has joined Arcus Biosciences (NASDAQ: RCUS) as Chief Operating Officer . . . and Roger Perlmutter is retiring as Executive Vice President and President of Merck Research Laboratories.
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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