is

Regeneron says antibody for COVID-19 could be ready this year

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




is

Lannett to Be U.S. Distributor of Posaconazole Delayed-Release Tablets

Click to view a price quote on LCI.




is

Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia

Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia.




is

Pre-filled Syringes San Francisco Conference 2020

14 - 15 September 2020, San Francisco, USA.
The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.




is

Repurposing existing drugs for COVID-19 offers a more rapid alternative to a vaccine

Repurposing existing medicines focused on known drug targets is likely to offer a more rapid hope of tackling COVID-19 than developing and manufacturing a vaccine, argue an international team of scientists in the British Journal of Pharmacology today.

Since the emergence of the SARS-CoV-2 virus in late 2019, more than 3.5 million people are known to have been infected, leading to over 240,000 deaths worldwide from COVID-19, the disease caused by the novel coronavirus.




is

India remains on USTR list of IP problem countries

India continues to be on the 'Priority Watch List' of the US Trade Representative (USTR) for lack of…



  • Focus On/Generics/India/Intellectual property law/Legal/Patents & Trademarks/USA

is

US-Swiss partnership takes aim at rare heart condition

A new collaboration targeting rare heart diseases has been formed between California’s BioMarin Pharmaceutical…



  • BioMarin Pharmaceutical/Biotechnology/Cardio-vascular/Deals/DiNA-001/DiNAQOR/Licensing/Rare diseases/Research/Switzerland/USA

is

Positive Phase III data for Lupin’s trichomoniasis candidate

India’s Lupin has announced positive top-line results from its pivotal Phase III clinical trial to…



  • Antibiotics and Infectious diseases/Drug Trial/India/Lupin/Pharmaceutical/Research/Solosec/Symbiomix Therapeutics/Women's health

is

BRIEF—US court upholds Amgen Kyprolis patent

The US District Court in Delaware issued a decision upholding the validity of patent claims from three…



  • Amgen/Biotechnology/Cipla/Focus On/Kyprolis/Legal/Oncology/Patents & Trademarks/USA

is

EU-led coronavirus fundraiser targets initial 7.5 billion euros

A pledging conference led by the European Union (EU) has set an initial target of 7.5 billion euros ($8.1…



  • Anti-virals/Antibiotics and Infectious diseases/Coronavirus/EIB Group/Europe/Focus On/Government Affairs/Health Medical Pharma/Pharmaceutical/Public health

is

Gilead plans to meet rising tide of remdesivir demand

California’s Gilead Sciences has outlined a plan to ramp up production of newly USA-approved COVID-19…



  • Anti-virals/Coronavirus/Focus On/Gilead Sciences/Pharmaceutical/Production/Public health/Remdesivir/USA

is

Ferring in sight of finish line with first microbiome-based drug

Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland

is

Stockpiling spurs sales at Novo Nordisk in first quarter

Pandemic-based stockpiling among people with diabetes helped lift revenues beyond analysts’ expectations…



  • Biotechnology/Denmark/Diabetes/Financial/Management/Novo Nordisk/Ozempic/Research/Rybelsus/Tresiba/USA/Victoza

is

Bristol-Myers' CAR-T cell therapy meets with FDA delay

The submission of additional information, upon the request of the US regulator, has delayed the action…



  • Biotechnology/Bristol-Myers Squibb/Focus On/Immuno-oncology/lisocabtagene maraleucel/Regulation/Research/US FDA/USA

is

Otezla’s impact shown in milder psoriasis

Amgen’s Otezla (apremilast), a drug divested by Celgene ahead of its acquisition by Bristol-Myers Squibb,…



  • Amgen/Biotechnology/Dermatologicals/Drug Trial/Inflammatory diseases/Otezla/Research/USA

is

Bausch + Lomb licenses Stada and Xbrane’s Lucentis biosimilar

Eye health specialist Bausch + Lomb, part Bausch Health Companies, has entered into an exclusive licensing…



  • Bausch & Lomb/Bausch Health Companies/Biosimilars/Canada/Deals/Germany/Licensing/Lucentis/Ophthalmics/STADA Arzneimittel/Sweden/USA/Xbrane Biopharma AB/Xlucane

is

An important option in the fight against antimicrobial resistance

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA

is

Recordati 1st-qtr revenues rise 12% as income leaps more than 20%

Italian drugmaker Recordati has reported consolidated revenues for the first quarter of 2020 are 429.2…



  • Financial/Italy/Pharmaceutical/Recordati/Signifor

is

BRIEF—AbbVie finally completes acquisition of Allergan

US pharma major AbbVie has finally completed its $63 billion acquisition of Ireland-incorporated Allergan,…



  • AbbVie/Allergan/Companies
  • mergers and acquisitions/Ireland/Legal/Pharmaceutical/USA

is

jCyte out-licenses rare vision disorder treatment for $252 million

US biotech firm jCyte Inc has entered into a licensing agreement with Japanese ophthalmology specialist…



  • Biotechnology/Deals/Japan/jCell/jCyte Inc/Licensing/Ophthalmics/Rare diseases/Santen/USA/Vision disorder

is

Novartis taps real-life Cosentyx patients to thank healthcare workers, pledge patient support

Novartis is using familiar faces—real patients from its Cosentyx TV commercials—to thank healthcare workers and promise support for patients. It’s a shift away from product-centered TV ads as Novartis adjusts its Cosentyx DTC effort during the COVID-19 crisis to highlight resources for patients, the drugmaker said.




is

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. 




is

Amgen ramps up Otezla expansion effort with positive data in mild psoriasis

Amgen is planning to file for FDA approval of Otezla in mild to moderate plaque psoriasis based on new data showing patients on the drug experienced significant improvements in their symptoms. The label expansion will be key to Amgen's ability to recoup the $13.4 billion it paid to acquire the drug from Celgene last year.




is

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.




is

Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, resurrected late last year. But despite postponing the drug's FDA filing half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.




is

Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs

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.




is

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. 




is

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.




is

Germany's confirmed coronavirus cases rise by 1,251 to 168,551: RKI

The number of confirmed coronavirus cases in Germany increased by 1,251 to 168,551, data from the Robert Koch Institute (RKI) for infectious diseases showed on Saturday.




is

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.




is

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.




is

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.




is

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 [...]



  • biotech reading list

is

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

is

Twentieth Member of Casino-cheating Criminal Enterprise Pleads Guilty to Racketeering Conspiracy Targeting Casinos in the United States and Canada

Phat Ngoc Tran, 35, pleaded guilty today in San Diego to conspiring to participate in a racketeering enterprise, the “Tran Organization,” in a scheme to cheat at least 12 casinos across the United States and Canada out of millions of dollars. Tran admitted that he and his co-conspirators unlawfully obtained up to $2.5 million during card cheats.



  • OPA Press Releases

is

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

is

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

is

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

is

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

is

Imprisoned Spy and His Son Indicted on Charges of Acting as Russian Agents and Money Laundering

A federal indictment was unsealed today in U.S. District Court for the District of Oregon charging Harold James Nicholson, 58, of Sheridan, Ore., and Nathaniel James Nicholson, 24, of Eugene, Ore., with two counts of Conspiracy, one count of Acting as Agents of a Foreign Government, and four counts of Money Laundering.



  • OPA Press Releases

is

Former Shipping Executive Sentenced to 48 Months in Jail for His Role in Antitrust Conspiracy

A former high-level shipping executive was sentenced today to serve 48 months in jail and to pay a $20,000 criminal fine for his role in an antitrust conspiracy involving the transportation of goods to and from the continental United States and Puerto Rico by ocean vessel. This is the longest jail sentence ever imposed for a single antitrust charge.



  • OPA Press Releases

is

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

is

Former Lobbyist Pleads Guilty to Conspiracy to Commit Honest Services Fraud

A former lobbyist pleaded guilty today to conspiring with others to commit honest services fraud. Todd A. Boulanger, 37, pleaded guilty before U.S. District Judge Richard W. Roberts in the District of Columbia. According to court documents, Boulanger worked as a lobbyist from 1999 through 2004 with Jack Abramoff and others.



  • OPA Press Releases

is

Former Mendenhall, Miss., Police Chief Pleads Guilty to Using Excessive Force

Jimmy “Jimbo” Sullivan, the former chief of police in Mendenhall, Miss., pleaded guilty today to a felony civil rights violation, admitting that he used excessive force when he repeatedly stomped on the head of an arrestee.



  • OPA Press Releases

is

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

is

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

is

Former Mississippi County Deputy Sheriffs Plead Guilty to Civil Rights Violations

Former Tippah County, Miss., Deputy Sheriff Jeffrey Rogers, 35, pleaded guilty today to a one-count information charging him and former Deputy Sheriff William Rogers with violating the civil rights of an arrestee. William Rogers, 56, who is Jeffrey Rogers’ father, pleaded guilty on Jan. 20, 2009, to the same charge of violating the civil rights of an arrestee.



  • OPA Press Releases

is

Government Contractor Sentenced to 30 Months in Prison on Bribery Charges

A government contractor and former employee of the U.S. Department of the Treasury was sentenced in Washington today in connection with a bribery scheme involving contracts at the U.S. Tax Court in the District of Columbia. Daniel Money, 44, of Shady Side, Md., was sentenced by U.S. District Judge Ricardo M. Urbina of the U.S. District Court for the District of Columbia, to 30 months in prison, three years supervised release and a $7,500 fine.



  • OPA Press Releases

is

Former Memphis Police Officer Found Guilty on 44 Counts of Civil Rights, Narcotics, Robbery and Firearms Charges

A federal jury in Memphis, Tenn., today found Arthur Sease IV, a former Memphis Police Department officer, guilty on forty-four counts of civil rights, narcotics, robbery and firearms offenses. The evidence at trial showed that from November 2003 through April 2006, Sease conspired with other Memphis police officers to use their authority as law enforcement officers, including their service weapons, to rob suspected drug dealers of cash, cocaine and marijuana. Sease and his co-conspirators would then resell the stolen drugs for their own profit.



  • OPA Press Releases

is

Las Vegas Minister and Conspirator Sentenced in Tax Evasion Scheme

Michael Haynes, a practicing minister, and David Jett, both of Las Vegas, were sentenced to 37 months in prison and five years probation, respectively, by Chief U.S. District Judge Robert L. Hunt in Las Vegas. Haynes and Jett were also ordered to pay restitution of $834,000 and $150,000, respectively, to the U.S. Treasury.



  • OPA Press Releases