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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

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Global pharma and biotech’s fight against COVID-19: an investment perspective

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



  • Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK

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Assessing the long-term impact of COVID-19 on clinical research

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



  • Anti-virals/Cell and Gene Therapy/Coronavirus/CRA/Feature/Focus On/Global/In Depth/Pharmaceutical/Regulation/Research/Vaccines

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BRIEF—GSK completes sale of nutrition brands for £3.4 billion

GlaxoSmithKline has completed divestment of its Horlicks and other Consumer Healthcare nutrition products…



  • Companies
  • mergers and acquisitions/Deals/Financial/GlaxoSmithKline/India/Pharmaceutical/UK

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First targeted therapy for aggressive form of lung cancer approved by FDA

Late Wednesday, the US Food and Drug Administration said it has granted accelerated approved for Tabrecta…



  • Biotechnology/capmatinib/Focus On/Incyte Corp/Medical Devices and Diagnostics/Novartis/Oncology/Rare diseases/Regulation/Research/Switzerland/Tabrecta/USA

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Novel ADC continues on path to blockbuster status

Tokyo’s Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) for trastuzumab deruxtecan…



  • Asia Pacific/AstraZeneca/Biotechnology/Daiichi Sankyo/Enhertu/Focus On/Japan/Oncology/Regulation/Research/trastuzumab deruxtecan/UK

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B-MS’ quarterly financials exceed estimates

US pharma major Bristol-Myers Squibb saw its revenue reach $10.8 billion in the first quarter of 2020,…



  • Bristol-Myers Squibb/Cardio-vascular/Celgene/Eliquis/Financial/Hematology/Immuno-oncology/Immunologicals/Management/Oncology/Opdivo/Orencia/Pharmaceutical/Pomalyst/Revlimid/USA

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Japan grants ‘exceptional’ approval for remdesivir in COVID-19

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



  • Anti-virals/Asia Pacific/Coronavirus/Focus On/Gilead Sciences/Japan/Pharmaceutical/Regulation/Remdesivir/USA/Veklury

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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

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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

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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

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Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner

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. 




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AbbVie CEO: Don't worry, Allergan's aesthetics clients still have money—and 'strong desire' for treatment

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.




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Gilead's remdesivir scores emergency FDA nod in COVID-19 days after big data reveal

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.




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With the world waiting, Roche socks $459M into COVID-19 antibody test production

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. 




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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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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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Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch

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.




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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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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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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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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.




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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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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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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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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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FDA grants emergency use authorization to Quidel for first antigen test for COVID-19

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.




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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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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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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

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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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Third Individual Pleads Guilty to Illegally Accessing Confidential Passport Files

A third individual pleaded guilty today to illegally accessing numerous confidential passport application files. Gerald R. Lueders, 65, of Woodbridge, Va., pleaded guilty before U.S. Magistrate Judge Alan Kay in U.S. District Court for the District of Columbia to a one-count criminal information charging him with unauthorized computer access.



  • 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