Drug Discovery and Development

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is…

AI-powered drug discovery company Exscientia announced that it completed a $225 Series D funding round. SoftBank Vision Fund 2 led the funding round, while previous lead investors, Novo Holdings and funds managed by Blackrock, contributed. Other investors included Mubadala Investment Company, Farallon Capital, Casdin Capital, GT Healthcare Capital, Marshall Wace, Pivotal bioVenture Partners, Laurion Capital,…

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the…

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to…

Former HUD Secretary Dr. Ben Carson, Sr. will assist Galectin Therapeutics Inc. (NSDQ: GALT) with the development of its galectin-3 inhibitor, belapectin. The drug is a potential treatment for nonalcoholic steatohepatitis (NASH), which is also known as nonalcoholic fatty liver disease.  Galectin Therapeutics has an ongoing Phase 2b/3 trial to investigate belapectin’s potential in treating cirrhosis…

Ovid Therapeutics (NSDQ:OVID) has named MIT professor Robert Langer as the chair of its scientific advisory board. The biopharma company focuses on rare neurological diseases. “The neurosciences are on the cusp of a scientific and, hopefully, therapeutic revolution,” said Langer in a statement. “Ovid has an exciting approach to tackling the key questions that drive…

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from…

The European Medicines Agency confirmed that the benefits of the COVID-19 vaccine from Johnson & Johnson (NYSE:JNJ) outweigh risks of blood clots. At a meeting today, EMA’s safety committee (PRAC) concluded that there is a link between unusual blood clots with low blood platelets with the COVID-19 vaccine made by J&J’s Janssen Pharmaceuticals unit. PRAC…

The FDA announced today that it approved Opdivo (nivolumab) in combination with chemotherapy to treat gastric cancer, among other diseases. Opdivo, developed by Bristol-Myers Squibb, when used in combination with certain types of chemotherapy is designed to treat advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. It is now the first FDA-approved…

Thermo Fisher Scientific (NYSE:TMO) announced today that it agreed to acquire PPD (NSDQ:PPD) for $17.4 billion. The boards of directors for both companies approved the definitive agreement which will see Thermo Fisher buy PPD at a price of $47.50 per share, totaling the $17.4 billion, plus the assumption of approximately $3.5 billion of net debt,…

Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson. According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the…

Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday. The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot…

The FDA and CDC issued a joint statement today recommending the pause in the administration of the Johnson & Johnson COVID-19 vaccine. As of yesterday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood…

The co-administration of drugs is commonplace for therapeutic proteins (TP). Yet, drug developers may face delays or ambiguity in preparing for clinical trials if they don’t plan for preliminary analysis of drug-drug interactions (DDI). Fortunately, the U.S. Food and Drug Administration (FDA) released in August 2020 new draft guidance for DDI assessment of TPs. The…

The pandemic has forced a rethink of clinical research, but the pharma industry continues to rely on animal testing. While pundits have observed that computer modeling and techniques such as microdosing can reduce animal testing, animal testing continues to be integral in preclinical studies.  But computer models are now sufficiently accurate to predict many drugs’ response, said…

Intravacc is today touting positive pre-clinical results of its SARS-CoV-2 nasal spray vaccine candidate in non-human subjects. Bilthoven, Netherlands-based Intravacc’s SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) nasal spray candidate was observed in four groups of mice and four groups of hamsters, all of which received two intranasal immunizations on day one and day…

A patient with childhood blindness has gained durable vision improvement after a single injection of sepofarsen, an investigational RNA therapy. The patient had a rare genetic disorder known as Leber congenital amaurosis (LCA) that affects the retina and often causes severe visual impairment. Injection of sepofarsen led to measurable changes in the fovea, a depression…

What can the pharma industry do about the critical shortage of contract manufacturing organization (CMO) and contract development and manufacturing company (CDMO) facilities? For a growing number of young entrepreneurial drug companies, the answer is a middle ground between building their own facilities and outsourcing to the saturated CMO/CDMO market. This middle ground lies in…

COVID-19 has complicated oncology trials and care, slowing down the success seen against cancer. While the cancer death rate fell 29% between 1991 and 2017, according to the American Cancer Society, the coronavirus pandemic has threatened to interfere with oncology drug development trials. COVID-19’s disproportionate impact on oncology “Cancer patients have been disproportionately negatively affected…

MedTech Innovator announced today that its new BioTools Innovator accelerator program has launched. BioTools Innovator is intended to advance life science tools innovation and improve human health by accelerating the growth of startups developing and commercializing a wide range of biotech products, platforms and services, according to a news release. Across a three-month accelerator program,…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine…

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures,…

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies. Yesterday, Slaoui was terminated as the Galvani board of directors’ chair, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the…

The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants. The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines. The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former…

Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ. The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020. The cybercriminals…