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AstraZeneca now has a 'winning formula' for its COVID-19 vaccine, CEO says

Dec 28, 2020 8:41am
Following a trial error and a data release that only raised more questions, AstraZeneca now has a winning formula for its COVID-19 vaccine, CEO Pascal Soriot told the Sunday Times. (AstraZeneca)
AstraZeneca s early COVID-19 trial data not only fell short of Pfizer and Moderna s expectation-beating stats, they raised a host of questions thanks to a dosing error in one group of trial patients. But with the U.K. suffering under a new viral strain and a quick vaccine approval expected, CEO Pascal Soriot says AZ has a new winning formula.
In the company s original phase 3 trial, patients given a half dose followed by a full dose a month later were better protected than those who received two full doses. Soriot has said the company will need to conduct a new trial for U.S. authorization, but across the pond, Sky News reports a U.K. nod could come this week. ....

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Takeda offloads heart and metabolism drugs to 3-month-old Chinese firm for $322M

Dec 23, 2020 9:47am
Takeda is selling five cardiovascular and metabolism drugs in the Chinese market to local company Hasten Biopharmaceutic for $322 million. (Takeda)
Takeda has already exceeded the product sell-off goal it set alongside its Shire merger, but the Japanese pharma shows no sign of slowing down.
After making several geography-specific divestitures in different regions of the world, Takeda has turned to China. The company said Monday it agreed to offload some cardiovascular and metabolic drugs in the Chinese mainland to local firm Hasten Biopharmaceutic for $322 million.
The deal covers five drugs, including hypertension med Ebrantil (urapidil); the whole portfolio generated $109.5 million in sales for the fiscal year ended in March. ....

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GSK's ViiV gets EU approval for long-acting HIV injectable

Dec 22, 2020 7:59am
The European approval for ViiV Healthcare s HIV treatment Vocabria comes nine months after Health Canada became the first regulator to clear the drug. (artJazz/iStock/Getty Images Plus/Getty Images)(Photo by artJazz/iStock/Getty Images Plus/Getty Images)
ViiV Healthcare has won approval for its long-acting injectable HIV treatment Vocabria in Europe. The authorization clears ViiV to sell a drug that could reduce the number of doses patients need to take a year from 365 to six.
Combinations of oral antiretrovirals, such as ViiV’s own Combivir and Trizivir, form the backbones of treatment regimens that suppress HIV. However, compliance to daily regimens is imperfect, raising the risk levels of the virus will rise. ViiV also identified the fact daily doses constantly remind people of their infection and create fear of the inadvertent disclosure of HIV status as downsides to current regimens. ....

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A new administration is taking the White House—will the 'onshore' drug manufacturing movement keep building?

Dec 22, 2020 3:00am
Drug manufacturers are looking for a more local future for production post-COVID-19. (Pixabay)(Monica Alleven/Fierce Wireless)
With the COVID-19 pandemic perhaps entering its final phase as the first wave of vaccines approaches the market, one question left unanswered is the future of onshoring drug manufacturing an initiative that reached fever pitch in 2019 as nationwide lockdowns and geopolitical tension cast a spotlight on the global supply chain.
In 2019, congressional leaders across the aisle picked up steam on a suite of bills aimed at incentivizing and driving manufacturing redundancy in the U.S. to combat China and India s dominance in generic medicines and active pharmaceutical ingredients (APIs). ....

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Young but ambitious Taysha lays out $76M for commercial gene therapy plant

RA Session II, founder, president and CEO of Taysha (Taysha Gene Therapies)
Taysha Gene Therapies hit the ground running when it launched this spring, cruising through a $95 million series B straight to a $100 million IPO in September. With its lead program now approved for human trials in Canada, the company is sketching out plans for what it hopes will become its prime commercial manufacturing site.
Taysha leased a 187,000-square-foot commercial-scale manufacturing facility in Durham, North Carolina, planning to invest $75 million to kit out the facility for preclinical, clinical and commercial gene therapy production. It’s also due to receive up to $9.4 million in state and local incentives for the project, Taysha said in a release. ....

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