Two antibody cocktails for COVID-19 could be available as early as this autumn

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The ongoing spread of COVID-19 in Russia is leading to shortages of drugs against orphan diseases in…

A collaboration in COVID-19 between immunology specialist Vir Biotechnology and Alnylam Pharmaceuticals…

A new collaboration between Shanghai’s Junshi Biosciences and Eli Lilly will seek to develop novel…

The COVID-19 pandemic did not stop China from launching its national blockchain-based service network…

As with other companies, US drug giant Pfizer and its German partner BioNTech are moving forward their…

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…

The fallout from the COVID-19 pandemic has been challenging for many life sciences companies due to a…

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality. Now, to cover its booming production goals, Roche plans to infuse nearly half-a-billion dollars into its German manufacturing facility. 

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.

With its multibillion-dollar restructuring plan in the rearview mirror, Teva is pinning its future growth on two of its branded meds with high hopes. But generics are still central to the Israeli drugmaker's business, and increased demand due to COVID-19 gave Teva a welcome gift in the first three months of the year.

Bristol Myers Squibb CEO Giovanni Caforio credited COVID-19-related stocking for high sales of some products in the first quarter, including Eliquis, a blood thinner that's being snapped up to reduce clotting risk in patients with the virus. But the pandemic has limited access to oncology clinics and other non-COVID-19 services, raising challenges that could impact sales later this year.

Global Blood Therapeutics' sickle cell disease medicine Oxbryta got off to a hot start after a November FDA approval. But early in its launch, execs now say they're seeing a "clear headwind" from the COVID-19 pandemic. Lately, new patient starts have tanked by 60%, CEO Ted Love said.

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections. 

Gilead Sciences has captured worldwide attention with its COVID-19 antiviral, remdesivir, cleared late last week by the FDA—not all of it welcome. With bad actors targeting companies at the head of the spear in the pandemic response, Gilead may have found itself in their sights.

U.S. Food and Drug Administration Commissioner Stephen Hahn is in self-quarantine for a couple of weeks after coming into contact with someone who tested positive for COVID-19, an FDA spokesman told Reuters late on Friday.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

The U.S. Food and Drug Administration (FDA) on Saturday approved emergency use authorization (EUA) to Quidel Corp for the first COVID-19 antigen test.

Closing out another year at BiotechDueDIligence, thank you for following along! Enjoy another round-up of scientific and medical journal articles driving the conversation and newsflow in biotech.There's lots of great #immunology in @sciencemagazine this week! @JSRustenhoven & @jonykipnis (@kipnislab @UVA) author a fascinating Perspective on how immune cells bypass the blood–brain barrier!https://t.co/6QjcNxU0p6 pic.twitter.com/njjnrn9Yej— Seth Thomas Scanlon (@ImmunoEditor) December 20, [...]

The United States has recovered more than $19 million from AMEC Construction Management Inc. (ACMI) to resolve allegations of fraud, false claims and kickbacks on four General Services Administration (GSA) construction contracts, as well as litigation over claims by the GSA for excess re-procurement costs incurred by GSA after it terminated ACMI’s contract to build the Thomas F. Eagleton United States Courthouse in St. Louis, Missouri. ACMI was formerly known as Morse Diesel International Inc.

A former Nazi concentration camp guard who settled in Racine, Wis., after World War II and acquired U.S. citizenship, has been removed to Austria due to his participation in Nazi-sponsored acts of persecution during World War II. Josias Kumpf, 83, served as an armed SS Death’s Head guard at the Nazi-run Sachsenhausen Concentration Camp in Germany and at the Trawniki Labor Camp in Poland.

Lazare Kabaya Kobagaya, 82, of Topeka, Kan., was arrested today on charges of naturalization fraud and misuse of an alien registration card. According to the indictment, Kobagaya allegedly participated in genocidal activities during the 1994 Rwandan conflict including mobilizing attackers to commit arson and murder. Kobagaya is alleged to have failed to disclose his alleged participation in these activities during his immigration and naturalization processes.

The U.S. Court of Appeals for the Fifth Circuit today rejected a challenge to the conviction of James Ford Seale, a former member of the White Knights of the Ku Klux Klan of Mississippi. Seale was convicted by a federal jury in Mississippi in 2007 and sentenced to three life terms in prison.

Jefferson Calimlim Sr. and his wife, Elnora Calimlim, both medical doctors in Milwaukee, Wis., were each sentenced today to 72 months in prison for forcing a woman to work as their domestic servant and illegally harboring her for 19 years in their Brookfield, Wis., residence.

The Department’s Civil Rights Division held a conference today titled 2009 Title VI Conference: Celebrating the 45th Anniversary of the Legislation and Exploring Current Issues in Enforcement at the FDIC Conference Center in Arlington, Va. Approximately 400 representatives from federal, state and local agencies, community organizations and advocacy groups gathered to share new ideas and discuss trends in Title VI enforcement.

Madhatta Haipe, a citizen of the Philippines, has been extradited from the Philippines to face trial in the District of Columbia for various crimes relating to the hostage taking of U.S. and Philippine citizens in 1995.

“Rooting out fraud and safeguarding taxpayers from illegal conduct are among the Justice Department’s highest priorities,” said Tony West, the Assistant Attorney General for the Civil Division.

"The challenges facing law enforcement in tribal communities are enormous. The basic level of police protection that most Americans take for granted simply does not exist in many parts of Indian Country. We have a duty to change that."

The Puerto Rico Aqueduct and Sewer Authority (PRASA) has agreed to implement major capital improvements and upgrades to resolve alleged longstanding violations of the Clean Water Act at 126 drinking water plants across the island and violations of the Safe Drinking Water Act at three others.

A former Guatemalan special forces soldier was arrested today in Palm Beach County, Fla., for lying on his naturalization application about his participation in a 1982 massacre at a Guatemalan village known as Dos Erres.

A former Guatemalan special forces soldier was indicted today by a federal grand jury in Palm Beach County, Fla., for lying on his naturalization application about his participation in a 1982 massacre at a Guatemalan village known as Dos Erres.

A former member of the Bosnian Serb Army has left the United States to return to Serbia after a federal judge ordered his denaturalization based on concealment during his application for U.S. citizenship that he served in the military during the Bosnian war.

Gilberto Jordan, 54, a former Guatemalan special forces soldier, pleaded guilty today in Fort Lauderdale, Fla., to a federal charge of unlawfully procuring his U.S. citizenship, admitting that he lied on his naturalization application about his participation in a 1982 massacre at a Guatemalan village known as Dos Erres.