Drug Discovery and Development Archives - Page 154 of 159

Pfizer touts non-human preclinical trial results for COVID-19 vaccine candidate

Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials.

The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release.

In a viral infection model, macaques received two injections with 100 µg of the vaccine candidate and macaques that received saline control injections were challenged 55 days after the second immunization with a high viral inoculum of about 1 million plaque-forming units of SARS-CoV-2. Immunization with BNT162b2 reduced viral infection with no viral RNA detected in the lower respiratory tract of the immunized animals, while the control group demonstrated evidence of viral RNA.

Among the anti-viral effects demonstrated by the vaccine were concomitant…

AstraZeneca puts COVID-19 vaccine trial on hold

AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness.

The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III trial for the AZD1222 vaccine being developed in collaboration with Oxford University.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” an AstraZeneca spokesperson told Drug Discovery & Development in a statement. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the t…

Drug companies agree not to release COVID-19 vaccine until it’s ready

[Photo by Fusion Medical Animation on Unsplash]

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine.

The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.

Get the full story at our sister site, MassDevice.

LabCorp launches flu-COVID diagnostic combo

Laboratory Corporation of America (NYSE:LH) announced today that it launched its COVID-19, influenza A/B and RSV diagnostic combo.

The single-panel test is designed to detect multiple types of infections including the novel coronavirus, the flue and respiratory syncytial virus (RSV), helping doctors diagnose patients and inform decisions for treatment options.

Burlington, N.C.-based LabCorp’s testing method is aimed at easing the strain that could be put on the healthcare system in the U.S. if there is a significant flu/RSV season in which the symptoms are similar to COVID-19 and other respiratory viruses, according to a news release.

LabCorp is offering the test through doctors, hospitals and other authorized healthcare providers in the U.S., while the company has submitted an application to the FDA to offer the combined test through its Pixel by LabCorp collection kit to add convenience and accessibility.

The Pixel by LabCorp at-home test …

How Navitor could improve the way you age gracefully

[Photo by Glen Hodson on Unsplash]

Officials at Navitor Pharmaceuticals (Cambridge, Mass.) think they could help people increase their healthy years by developing more targeted therapeutics.

Products from its pipeline may soon pave the way for more effective treatments for conditions such as kidney disease, but how could the company shape the way we look at “aging gracefully?”

Drug Discovery & Development recently interviewed Navitor CEO Thomas E. Hughes for more insight into the organization and specifically, NV20494 — one of its lead product candidates.

Drug Discovery: Can you describe your personal background and the role you play at Navitor?

Hughes: I’ve spent the majority of my career [in] drug discovery and development, with a focus on diseases that have a basis in aging and nutrition. … I joined Novartis as a postdoctoral fellow in the late 1980s and worked there for almost 21 …

Nestlé to acquire peanut allergy drugmaker for $2.6B

Nestlé (VTX:NESN) announced today that it entered into a definitive agreement to acquire food allergy treatment developer Aimmune Therapeutics (NSDQ:AIMT).

Under the agreement, Nestlé Health Science (NHSc) would acquire Aimmune with a cash offer for $34.50 per share, totaling approximately $2.6 billion. The per-share price for Aimmune represents a 174% premium to the company’s closing share price of $12.60 on Aug. 28. Currently, shares of AIMT are trading up 171.6% at $34.22 per share. Nestlé plans to finance the transaction with cash on hand, according to a news release, with the acquisition set to close in the fourth quarter of 2020.

Currently, NHSc has a total investment in Aimmune of $473 million, totaling an approximate 25.6% equity ownership stake. NHSc made its initial investment ($145 million) in the company in November 2016, then invested $30 million in February 2018, $98 million in November 2018 and $200 million in January 2020.

Nestlé sa…

AstraZeneca denies it’s seeking an EUA for its COVID-19 vaccine candidate

AstraZeneca has denied news reports that the British pharmaceutical company is involved in talks with U.S. authorities about an emergency use authorization for its COVID-19 vaccine candidate.

The denial comes after recent news reports claiming the Trump administration is eyeing a plan to fast-track the vaccine candidate, AZD1222, before the upcoming Nov. 3 presidential election.

“AstraZeneca has not discussed emergency use authorization with the U.S. government, and it would be premature to speculate on that possibility,” AstraZeneca spokesperson Brendan McEvoy told Drug Discovery and Development via email..

While AstraZeneca has denied these discussions, that didn’t stop shares of the company to climb following news of the current U.S. presidential administration’s interest in securing the emergency use authorization for its vaccine.

According to a report from The Financial Times, members of the Trump team, including White House chief of staff Ma…

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

Get the full story on our sister site, Pharmaceutical Processing World.

A promising drug for COVID-19 survival?

Researchers at Hackensack Meridian Health are touting the drug tocilizumab as a treatment for critically ill COVID-19 patients in the ICU.

Observational data of hospitalized COVID-19 patients shows that tocilizumab, generally used to treat rheumatoid arthritis and cancer, improves hospital survival in the critically ill ICU patients, according to a news release.

The researchers published results in The Lancet Rheumatology last week and subsequently updated the FDA and other national leaders with information from the observations in an effort to potentially accelerate improved outcomes.

A total of 630 patients admitted to the ICUs of 13 Hackensack Meridian Health hospitals between March 1 and April 22 (the height of the pandemic in New Jersey) were observed. Tocilizumab was considered for off-label usage in patients whose respiratory symptoms were declining, many of whom required mechanical ventilator support. In the study, 210 patients received the drug,…

Johnson & Johnson to acquire Momenta for $6.5B

Johnson & Johnson (NYSE:JNJ) announced today that it entered into an agreement to purchase Momenta Pharmaceuticals (NSDQ:MNTA) for $6.5 billion.

New Brunswick, N.J.-based Johnson & Johnson will stump up the $6.5 billion in an all-cash transaction for the developer of novel therapies for immune-mediated diseases, according to a news release.

Momenta felt the full effect of the news of the acquisition breaking, as shares of MNTA were trading up 69.2% at $52.13 per share in late-afternoon trading today.

The acquisition is seen by Johnson & Johnson as an opportunity for its Janssen Pharmaceutical subsidiary to broaden its work in immune-mediated disease and drive growth through expansion into autoantibody-driven diseases.

Included in the acquisition are the full global rights to Momenta’s nipocalimab (M281) anti-FcRn antibody, for which Janssen plans to pursue indications across autoimmune diseases with unmet medical needs in materna…

Feds accuse Teva of $300M in kickbacks for MS drug

Massachusetts federal prosecutors today claimed that Teva Pharmaceuticals funneled $300 million from a pair of charitable foundations to subsidize Medicare copayments for a multiple sclerosis drug.

Teva Pharmaceuticals and Teva Neuroscience, the maker of Copaxone, simultaneously raised the drug’s price by 329%, allegedly violating the Anti-Kickback Statute and False Claims Act, according to the complaint filed by the U.S. Attorney’s Office in Boston.

The government alleges that Teva conspired with a specialty pharmacy, Advanced Care Scripts, Inc. (ACS), and two purportedly independent foundations, Chronic Disease Fund (CDF) and The Assistance Fund (TAF).

When a Medicare beneficiary obtains a prescription drug covered by Medicare Part B or Part D, the beneficiary may be required to make a co-payment, which can be substantial for expensive medications. The Anti-Kickback Statute prohibits pharmaceutical companies from offering or paying, directl…

Medtech stocks help boost S&P rally

Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic.

Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more than 50% since the index’s previous record high before the pandemic in February.

Get the full story at our sister site, MassDevice.