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When will COVID-19 vaccines be widely available? Feds lay out an ambitious timeline

With Moderna and Pfizer both reporting sky-high response rates to their COVID-19 vaccines, the pressure is on federal health officials to ensure a rapid—but smooth—rollout. Wednesday, they unveiled a
2020/11/18
Alnylam scores European approval for rare disease med Oxlumo, plans 'sustainable' access deals

After years of research into RNAi medicine lumasiran, rare disease drugmaker Alnylam has scored its regulatory nod for the drug, to be marketed as Oxlumo, in the ultra-orphan rare disease primary hyp
2020/11/18
CDMO August Bioservices, riding the 'onshore' movement, plots sterile injectable facility in Tennessee

With tensions running high amid COVID-19 and a trade war with China, the "onshoring" movement for drug production has escalated in recent months and seen some pretty sizable investments. Now, a Tenne
2020/11/18
Viatris' growth story hinges on M&A as China, Japan hang in the balance: analyst

After months of delay thanks to a U.S. antitrust roadblock, Pfizer and Mylan finallywrapped uptheir generics merger on Monday.Enter Viatris, which hopes the additional geographic reach offered by Pfi
2020/11/17
Celltrion plots $453M South Korean expansion to aid ambitious biosimilar pipeline push: report

South Korea's Celltrion has made its name recently with biosimilar copies of big-name blockbusters, and it has plans to add even more in the coming years. To get there, Celltrion is betting big on an
2020/11/17
NICE's thumbs-up on Lilly's migraine med Emgality leaves rivals from Novartis and Teva in the dust

England's drug cost watchdogs have not been gentle on companies marketing hot but expensive new CGRP inhibitors to treat migraine headaches. But they just made an exception for one of those companies
2020/11/16
Airlines rally cold-chain supplies to ship Pfizer, Moderna's frigid COVID-19 shots

Positive data on Pfizer and Moderna's mRNA vaccine candidates havebeen tempered in recent weeks by concerns over shipping hurdles for the shots, both of which require stringent temperature controlto
2020/11/16
Despite impressive data, FDA's coronavirus vaccine reviews will take weeks, not days, official says

As leading COVID-19 vaccinespost positive phase 3 data and nearFDA submissions, the agency official in charge of reviewingvaccinesis emphasizing transparency andpatienceduringthehigh-stakes process.
2020/11/13
CureVac, armed with COVID-19 vaccine deal, plots 'pandemic-scale' Euro manufacturing expansion

As Pfizer and Moderna dominate headlineswith positive interim readoutsfor their COVID-19 vaccine candidates, othermRNA players are taking note. Germany's CureVac, hot on the heels of an EU supplydeal
2020/11/13
Cambrex looks to fill 'onshore' API manufacturing demand with $50M expansion in Iowa

With the COVID-19 pandemic nearing its second year in the U.S., lawmakers have bangedthe drum on boosting "onshore" production of key pharmaceuticals and ingredients to ensure supply-side security. N
2020/11/6

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