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Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says

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.




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Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

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.




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AbbVie, Allergan score FTC approval for $63B merger with one final hurdle left to go

AbbVie and Allergan have waited for nearly a year for their much-discussed merger to pass muster. Finally, after pushback from consumer groups and tight scrutiny from regulators, the FTC has granted its green light. The partners face just one final hurdle to consummating their deal. 




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Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says

After his surprise removal from HHS’ Biomedical Advanced Research and Development Authority—a key agency partnered with pharma companies on COVID-19 drugs, vaccines and diagnostics—former Director Rick Bright is alleging whistleblower retaliation by HHS leadership. 




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AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes

AstraZeneca has watched superstar SGLT2 diabetes med Farxiga nail trial after trial in highly coveted kidney and heart failure indications, with the FDA expediting reviews to back them up. The one thing AstraZeneca was missing? The agency taking Farxiga across the finish line. 




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Fresenius Kabi recalls anti-inflammation drug Ketorolac after finding particles in vials

German drugmaker Fresenius Kabi has made major investments in its U.S. manufacturing operations in recent years with some mixed quality results along the way. Now, one of the drugmaker's products faces a recall for more manufacturing woes.




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Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir

The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.




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GBT chief blames COVID-19 for 'clear' slowdown in Oxbryta launch, but analysts are still impressed

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.




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FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact

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.




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Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report

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. 




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Early missteps, transparency questions dog U.S. government's remdesivir rollout: reports

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 




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Roche's Kadcyla wins NICE backing in early breast cancer use

Unlike its first U.K. reimbursement negotiations, Roche’s HER2 antibody-drug conjugate has won quick National Institute for Health and Care Excellence backing for routine NHS coverage to prevent HER2-positive breast cancer from returning after surgery in the so-called adjuvant setting.




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Gilead hit with Iranian cyberattack for role in COVID-19 response: report

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.




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Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.




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U.S. CDC reports 1,248,040 coronavirus cases, 75,477 deaths

The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.




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China reports one new coronavirus case, 15 asymptomatic cases

China reported one new coronavirus case for Friday, unchanged from the day before, data from the national health authority showed on Saturday.




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FDA commissioner in self-quarantine after exposure to person with COVID-19

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.




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Thailand reports four new coronavirus cases, one new death

Thailand reported four new coronavirus cases and one more death on Saturday, bringing the total to 3,004 cases and 56 deaths since the outbreak started in January.




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China to reform disease prevention system

China will reform its disease prevention and control system to address weaknesses exposed by the coronavirus outbreak, a senior health official said on Saturday.




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Singapore reports 753 new coronavirus cases, taking total to 22,460

Singapore registered 753 new coronavirus infections, its health ministry said on Saturday, taking the city-state's total to 22,460 cases.




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China approves Novartis' multiple sclerosis treatment Mayzent

Chinese regulators have approved Novartis' Mayzent to treat relapsing multiple sclerosis in adults, the Swiss drug maker said in a statement on Saturday.




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Russia records more than 10,000 new coronavirus cases in past day

Russian authorities said on Saturday they had recorded 10,817 new cases of the coronavirus in the last day, pushing the nationwide tally to 198,676.




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Philippines' coronavirus deaths breach 700

The Philippines' health ministry reported on Saturday that coronavirus deaths have reached more than 700.




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Tokyo reports 36 new cases of coronavirus infection on Saturday: TV Asahi

Tokyo reported 36 new cases of coronavirus infections on Saturday, TV Asahi said, three less than a day earlier and the seventh consecutive day that new infections have remained below 100.




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Indonesia reports 533 new COVID-19 cases, biggest in a day

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.




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Malaysia reports 54 new coronavirus cases and one new death

Malaysia health authorities on Saturday reported 54 new coronavirus cases for a total of 6,589.




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Slovakia records no new coronavirus cases for first time since March 10

Slovakia on Friday recorded no new cases of coronavirus for the first time since March 10, government figures showed.




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Tijuana coronavirus death rate soars after hospital outbreaks

The number of deaths from the coronavirus in Mexico's best-known border city, Tijuana, has soared and the COVID-19 mortality rate is twice the national average, the health ministry says, after medical staff quickly fell ill as the outbreak rampaged through hospital wards.




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New York governor says 5-year old died from rare COVID-related complications

A 5-year old boy has died in New York from a rare inflammatory syndrome believed to be linked to the novel coronavirus, highlighting a potential new risk for children in the pandemic, Governor Andrew Cuomo said on Friday.




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Factbox: Latest on the worldwide spread of the coronavirus

More than 3.95 million people have been reported to be infected by the novel coronavirus globally and 273,805 have died, according to a Reuters tally, as of 0214 GMT on Saturday.




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Best of the Best Biotech Book Recommendations

As you may know, I maintain an extensive list of book recommendations for the biotech enthusiast on a "Amazon Influencer" page. After the latest update there are well over 100 titles! I recently analyzed the data to come up with the most popular titles among my followers (perhaps the full list is a bit intimidating):​Genentech: The Birth of BiotechThe Biotech Trader HandbookThe Pharmagellan Guide to Biotech Forecasting & ValuationValuation in Life Sciences: A Practical GuideThe Antidot [...]




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Biotech Reading List

I Thought Being a Health Care Reporter Would Make Cancer Easier. I Was Wrong.Alexandra Glorioso (Politico Magazine)Meet the pigs that could solve the human organ transplant crisisKaren Weintraub (MIT Technology Review)The Director of the NIH Lays Out His Vision of the Future of Medical ScienceFrancis Collins (Time)In a rural Wisconsin village, the doctor makes house calls — and sees some of the rarest diseases on EarthMark Johnson (Milwaukee Journal Sentinel)‘I just want to live [...]



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Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime

A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate.



  • OPA Press Releases

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Puerto Rico Senator Jorge De Castro Font Pleads Guilty to Honest Services Wire Fraud and Conspiracy to Commit Extortion

Jorge De Castro Font, 45, a former senator in the Commonwealth of Puerto Rico, pleaded guilty today to 20 counts of honest services wire fraud and one count of conspiracy to commit extortion.



  • OPA Press Releases

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LAN Cargo S.A., Aerolinhas Brasileiras S.A. and EL AL Israel Airlines Ltd. Agree to Plead Guilty for Fixing Prices on Air Cargo Shipments

Three air cargo carriers, LAN Cargo S.A. (LAN Cargo), Aerolinhas Brasileiras S.A. (ABSA), and EL AL Israel Airlines Ltd. (EL AL), have each agreed to plead guilty and pay criminal fines totaling $124.7 million for their roles in a conspiracy to fix prices in the air cargo industry.



  • OPA Press Releases

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Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.



  • OPA Press Releases

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Foreign National Sentenced to Five Years in Prison for Smuggling East Africans to the United States

A Ghanian man was sentenced today in the District of Columbia for his role in smuggling East Africans into the United States. Mohammed Kamel Ibrahim, a/k/a Hakim, 27, a native of Ghana and naturalized citizen of Mexico, was sentenced to five years in prison by U.S. District Judge Ricardo M. Urbina after pleading guilty to one count of conspiracy and three counts of bringing aliens to the United States for profit.



  • OPA Press Releases

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Canadian Company to Pay U.S. More Than $1 Million Related to Sale of Defective Bullet-proof Vests

Barrday Inc. and two related companies have agreed to pay the United States more than $1 million to resolve allegations that they violated the False Claims Act in connection with their role in the weaving of Zylon fabric used in the manufacture and sale of defective Zylon bullet-proof vests. Barrday, headquartered in Cambridge, Ontario, Canada, is a weaver of ballistic fabrics and designs and produces specialty industrial textiles.



  • OPA Press Releases

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Former Oak Ridge Complex Employee Pleads Guilty to Unlawful Disclosure of Restricted Atomic Energy Data

Roy Lynn Oakley, 67, a resident of Harriman, Tenn., pleaded guilty today in U.S. District Court in Knoxville, to count one of an indictment charging him with unlawful disclosure of Restricted Data under the Atomic Energy Act, in violation of 42 U.S.C., Section 2274(b).



  • OPA Press Releases

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Three Men Indicted for Racially-Motivated Church Arson in Springfield, Mass.

Three individuals were indicted today by a federal grand jury in the District of Massachusetts for conspiring to interfere with the civil rights of members of the Macedonia Church of God in Christ, a Springfield, Mass., church with a predominantly African-American congregation.



  • OPA Press Releases

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Former AIG Vice President Sentenced to Four Years in Prison for Role in Fraudulent Manipulation Scheme

The former vice president of reinsurance of American International Group Inc. (AIG), was sentenced today to four years in prison for his role in a fraudulent scheme to manipulate AIG’s financial statements.



  • OPA Press Releases

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Owner of Pharmaceutical Wholesale Company Pleads Guilty to Medicare Fraud

The owner and operator of HME Solutions Inc., dba Lifecare Medical (Lifecare Medical), a licensed pharmaceutical wholesale company in Miami, pleaded guilty today to defrauding the Medicare program in connection with a $5.3 million HIV-infusion fraud scheme.



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Justice Department Settles Allegations of Disability and Religious Discrimination Against Nashville, Tenn.

The Department today announced a settlement resolving allegations that the Metropolitan Government of Nashville and Davidson County (Metropolitan Government) violated the Fair Housing Act (FHA) and the Religious Land Use and Institutionalized Persons Act (RLUIPA) by discriminating against Teen Challenge, a Christian substance abuse treatment program.



  • OPA Press Releases

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Justice Department Settles Lawsuit Alleging Gender Discrimination and Retaliation by the Puerto Rico Police Department

The Department today announced that it has reached a consent decree with the Policía de Puerto Rico (Puerto Rico Police Department or PRPD) that will, if approved by the federal district court, resolve a complaint the Department filed in March 2008 alleging that the PRPD engaged in unlawful employment discrimination based on gender and retaliation, in violation of Title VII of the Civil Rights Act. Title VII prohibits employment discrimination on the basis of race, color, sex, national origin and religion, and also prohibits retaliation against persons for filing charges of discrimination.



  • OPA Press Releases

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Two Oklahoma County Corrections Officers Indicted for Federal Civil Rights Violation in Death of Oklahoma City Man

A federal grand jury indictment was unsealed today in Oklahoma City charging corrections officers Gavin Littlejohn, 25, of Oklahoma City, and Justin Isch, 21, of Edmond, Okla., with a federal civil rights violation for the fatal assault of Christopher Beckman at the Oklahoma County Detention Center in May 2007.



  • OPA Press Releases

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U.S. Recovers $19 Million from AMEC Construction Management to Settle Litigation Regarding Fraud, False Claims, Kickbacks & Re-Procurement Costs on Federal Construction Contracts

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.



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Justice Department Settles Lawsuit on Behalf of Kansas Air Force Reservist

The Department today announced a settlement that, if approved by the court, will resolve allegations in a lawsuit the Department filed on behalf of Randall A. Slocum, an Air Force Reservist, against the city of Iola, Kan. The complaint, filed in December 2008, alleged that the city of Iola violated the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA) by taking into consideration Slocum’s military service obligations when it disciplined him and denied him a wage increase.



  • OPA Press Releases

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Justice Department Settles Religious Discrimination Lawsuit Against Washington Metropolitan Area Transit Authority

The Department announced today that it has entered into a settlement agreement with the Washington Metropolitan Area Transit Authority (WMATA) that, if approved by the court, will resolve the complaint of pattern or practice religious discrimination filed by the United States against WMATA under Title VII of the Civil Rights Act of 1964.



  • OPA Press Releases

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Former Finance Director of California Valve Company Pleads Guilty to Bribing Foreign Government Officials

The former finance director of an Orange County, Calif.-based valve company pleaded guilty today in connection with his role in a conspiracy to pay approximately $628,000 in bribes to numerous foreign government officials.



  • OPA Press Releases

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Coal-Fired Power Plant to Spend More Than $135 Million to Settle Clean Air Violations

Kentucky Utilities (KU), a coal-fired electric utility, has agreed to pay a $1.4 million civil penalty and spend approximately $135 million on pollution controls to resolve violations of the Clean Air Act.



  • OPA Press Releases