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Pfiz­er, My­lan deal takes a coro­n­avirus hit

Apart from R&D disruption, another casualty of the coronavirus epidemic is dealmaking, or in this case, completing planned mergers. In July 2019, Pfizer — Mylan’s manufacturing partner for its flagship EpiPen — inked a deal to combine its off-patent drug business with the generic drugmaker. The deal, which was initially expected to close mid-2020 will now close in the second half of the year.

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EMA of­fers method­olog­i­cal con­sid­er­a­tions for tri­als dur­ing Covid-19 pan­dem­ic

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline on points that clinical trial sponsors should consider on the implications of the coronavirus disease (Covid-19) on methodological aspects of ongoing trials.

While noting that “it is not possible to give general applicable advice on how the different aspects related to the pandemic should be handled, as implications on clinical trials are expected to be manifold,” the EMA’s Biostatistics Working Party calls on sponsors “to pre-plan how systematic deviations resulting from the measures and individual decisions related to the Covid-19 pandemic are captured,” as well as to record such deviations and the related reasons for them.

Covid-19 roundup: Bris­tol My­ers sus­pends clin­i­cal tri­als, grounds field team; Vir ush­ers an­ti­body can­di­dates to hu­man test­ing

The global nature of the Covid-19 pandemic is manifesting more profoundly every day. With Spain’s death toll now surpassing China’s and India on full lockdown, the number of confirmed cases around the world has exceeded 436,000 while recoveries edged close to 112,000.

While the outbreak derails R&D at another pharma giant, several drugmakers have some encouraging updates on both experimental and repurposed molecules. Philanthropic campaigns in anticipation of the economic fallout continue. An Australian biotech is taking extreme measures to hunker down. There’s also an alternative epidemiology model emerging out of the UK, stirring up more discussion regarding the true extent of the infections in the country.

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FDA is­sues an­oth­er safe­ty alert re­lat­ed to fe­cal trans­plants, as da­ta sug­gest coro­n­avirus lingers in poop

Since 2013, the FDA has implemented a policy of “enforcement discretion” regarding fecal microbiota transplants (FMT) to treat refractory C. diff: While biopharma companies work on developing standardized products, physicians can conduct FMT’s after securing reasonable consent from patients. But since last summer, a handful of safety issues have caused a stir in the field.

Earlier this week, the FDA issued a safety alert highlighting the risk of potential transmission of the new coronavirus from fecal matter derived from donors used in FMT, and said that additional safety measures are necessary.

FDA opens door to emer­gency use of con­va­les­cent plas­ma from re­cov­ered Covid-19 pa­tients

One potential treatment for Covid-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease, and the FDA said Tuesday that it will help to provide access to it for patients with serious or immediately life-threatening Covid-19 infections.

The idea behind the treatment is that plasma collected from patients recovering from Covid-19 may contain antibodies to the virus that might be effective against the infection. New York Gov. Andrew Cuomo (D) said yesterday that some critically ill patients would be able to access convalescent plasma in some cases.

Covid-19 roundup: Where is Dr. Fau­ci?; AS­CO goes vir­tu­al

In another blistering press conference on Monday, President Trump indicated he was keen to reopen the US economy in weeks, not months, even as the death toll from the coronavirus continues to mount. “Our country wasn’t built to be shut down … we cannot let the cure be worse than the problem itself,” he declared.

In contrast, UK Prime Minister Boris Johnson told citizens in a somber address: “if you don’t follow the rules, the police will have the powers to enforce them,” as he unleashed a long-anticipated three-week lockdown.

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An employee checks the production of chloroquine phosphate at a pharmaceutical company in Nantong city in east China's Jiangsu province, Thursday, Feb. 27, 2020. (Getty Images)

'I have a feel­ing': Trump-en­dorsed malar­ia drug fails to pass muster in small Chi­nese coro­n­avirus study

Despite the FDA’s reluctance to endorse without definitive clinical trial data the decades-old anti-malarial drugs chloroquine and derivative hydroxychloroquine as treatments to combat the coronavirus scourge, in recent days President Trump has trumpeted his faith — on the basis of a ‘feeling’ — that the drugs would work. Now, a key analyst has found trial data that contradict the positive conclusions of a small Chinese study that researchers initially based on their enthusiasm on.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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Covid-19 roundup: FDA stamps quick OK on Roche's Actem­ra PhI­II; AlloVir ex­pands Bay­lor pact

→ The FDA has offered a quick OK for Genentech to start a Phase III trial using their rheumatoid arthritis drug Actemra against Covid-19. And the big Roche subsidiary is sending in 10,000 doses for the US stockpile.

Genentech is working with BARDA on the study, which has established primary and secondary endpoints that include “clinical status, mortality, mechanical ventilation and intensive care unit (ICU) variables.”

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In­un­dat­ed by de­mand, Gilead halts in­di­vid­ual emer­gency ac­cess to ex­per­i­men­tal Covid-19 drug

Slammed with a tidal wave of compassionate use requests, Gilead says it will have to put a halt to meeting individual appeals for their coronavirus drug remdesivir while they focus on wrapping a clinical trial to see if it works.

In recent days, the anti-malarial drug chloroquine and similar drug hydroxychloroquine have soaked up the spotlight as potential “game-changers” to combat the coronavirus scourge that has enveloped the globe. But Gilead’s antiviral remdesivir was one of the first to be touted as a potential therapy and is also one of the furthest along the path towards approval.

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