ut

Portola Pharmaceuticals to merge with Alexion in $1.41bn cash deal

Alexion has announced it is to acquire Boston-based blood disorder specialist Portola Pharmaceuticals in a transaction to the value of $1.41 billion in cash.




ut

South Korea says Ebola drug remdesivir may not be suitable for all coronavirus patients

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.




ut

Scientists in the UK and US identify hundreds of mutations in the COVID-19 virus

Two studies from the UK and US have identified hundreds of mutations in COVID-19, which could cause problems for the development of a vaccine.




ut

Novo Nordisk trumpets NASH data with semaglutide

Results could unlock another big market for the company’s star drug




ut

Glutagenic Virus Protection Kit

The U.S. Food and Drug Administration posted a photo:

This product is promoted with unapproved claims to prevent, treat, mitigate, or cure COVID-19. FDA warns consumers to avoid unproven and potentially unsafe products. See the Warning Letter for more information:

www.fda.gov/inspections-compliance-enforcement-and-crimin...

More information is available at www.fda.gov/consumers/health-fraud-scams/fraudulent-coron...

Photo by FDA's Office of Regulatory Affairs, Health Fraud Branch

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to FDA's Office of Regulatory Affairs, Health Fraud Branch is appreciated but not required.




ut

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

Click to view a price quote on LCI.




ut

Oligonucleotide Therapeutics and Delivery Conference 2020

16 - 17 September 2020, London, UK.
Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA, RNAi, saRNA and siRNA. Their market growth: CAGR of 13.7% projected to reach USD 8.2 billion by 2024 is driven by their potential to provide more efficacious and less toxic alternatives to small molecules.




ut

AstraZeneca and Saint Luke’s Mid America Heart Institute initiate Phase III DARE-19 trial with Farxiga in COVID-19 patients

AstraZeneca and Saint Luke's Mid America Heart Institute have initiated a randomised, global Phase III trial to assess the potential of Farxiga (dapagliflozin) as a treatment in patients hospitalised with COVID-19 who are at risk of developing serious complications, such as organ failure.




ut

Supercomputer simulations present potential active substances against coronavirus

Several drugs approved for treating hepatitis C viral infection were identified as potential candidates against COVID-19, a new disease caused by the SARS-CoV-2 coronavirus. This is the result of research based on extensive calculations using the MOGON II supercomputer at Johannes Gutenberg University Mainz (JGU). One of the most powerful computers in the world,




ut

US FTC clears AbbVie’s buy of Allergan, but with divestments

Almost a year after the original announcement, the US Federal Trade Commission (FTC) has accepted the…



  • AbbVie/Allergan/Companies
  • mergers and acquisitions/Endocrinology/Federal Trade Commission/Ireland/Legal/Management/Pancrelipase/Pharmaceutical/USA/Viokace/Zenpep

ut

ALK Abello outperforms expectations in strong 1st-qtr

Shares of Danish allergy immunotherapy specialist ALK Abello were up almost 10% at 1,788.00 Danish kroner…



  • Acarizax/ALK Abello/Denmark/Financial/Immunologicals/Itulazax/Pharmaceutical

ut

Alexion exceeds earnings estimates but drops guidance

US drugmaker Alexion Pharmaceuticals fared better in its revenue and adjusted earnings figures in the…



  • Alexion Pharmaceuticals/Autoimmune Disorders/Biotechnology/Financial/Immunologicals/Management/Rare diseases/Soliris/Strensiq/Ultomiris/USA

ut

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

ut

PTC Therapeutics to acquire Censa Pharmaceutical

In another strategic M&A deal announced so far this month, PTC Therapeutics has entered into an agreement…



  • Biotechnology/Censa Pharmaceuticals/Companies
  • mergers and acquisitions/Metabolics/PTC Therapeutics/Rare diseases/sepiapterin/USA

ut

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

ut

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. 




ut

Seattle Genetics, Astellas' bladder cancer med Padcev blows early expectations out of the water

Even a pandemic can’t slow down Seattle Genetics and Astellas' new bladder cancer treatment Padcev, which "blew out sales expectations" for the first quarter, analysts said. And now, they're jacking up their long-term sales estimates for the drug as a result.




ut

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. 




ut

Teva generics benefit from COVID-19 bump––but the boom may not last

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.




ut

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.




ut

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.




ut

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.




ut

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. 




ut

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. 




ut

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.




ut

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.




ut

Tribute to Michael Becker

The world of biotech suffered a great loss in 2019 with the passing on Michael Becker. Be sure to take in the tributes to Michael from around the Twitterverse. [...]




ut

Former New York Power Authority Employee Sentenced to 37 Months in Jail for Bribery and Fraud Scheme

A former employee of the New York Power Authority (NYPA) was sentenced today to serve 37 months in jail and to pay a $5,000 criminal fine for his role in a kickback and bribery scheme.



  • OPA Press Releases

ut

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.



  • OPA Press Releases

ut

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

ut

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

ut

Three Foreign Executives Indicted for Their Roles in LCD Price-Fixing Conspiracy

A federal grand jury in San Francisco returned an indictment against two former executives from Chunghwa Picture Tubes Ltd. (Chunghwa) and one former executive from LG Display Co. Ltd. (LG) for their participation in a global conspiracy to fix prices of Thin Film Transistor-Liquid Crystal Display (TFT-LCD) panels.



  • OPA Press Releases

ut

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

ut

Federal Court Bars Connecticut Woman from Preparing Tax Returns for Others

A federal district court in Connecticut has permanently barred Elda Sinani, a resident of that state, from preparing federal tax returns for others. Sinani consented to the civil injunction order.



  • OPA Press Releases

ut

Arizona Man Sentenced to Five Years for Distribution of Child Pornography

Theodore Allan, 54, of Glendale, Ariz., was sentenced today to five years in prison for distribution of child pornography. Allan was indicted on charges of distribution, receipt and possession of child pornography on March 6, 2007.



  • OPA Press Releases

ut

Former Executive Indicted for His Role in Two Cathode Ray Tube Price-Fixing Conspiracies

A federal grand jury in San Francisco today returned a two-count indictment against the former Chairman and Chief Executive Officer of Chunghwa Picture Tubes Ltd. for his participation in global conspiracies to fix prices of two types of cathode ray tubes (CRTs) used in computer monitors and televisions.



  • OPA Press Releases

ut

Justice Department Seeks to Shut Down Texas Tax Preparers

The United States has sued a Dallas tax preparer, Tina Preston, her tax-preparation firm – Preston Tax Services, Inc. – and several other individuals associated with the firm, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Dallas with the U.S. District Court for the Northern District of Texas.



  • OPA Press Releases

ut

Five Defendants Convicted of International Sex Trafficking for Forcing Central American Girls and Women into Prostitution

Five defendants, all members or associates of an extended family, face potential life sentences after being found guilty of sex trafficking for participating in a scheme that lured young Central American women and girls into the Los Angeles area and forced them into prostitution. The defendants, four Guatemalan nationals and one Mexican citizen, were convicted on Feb. 11, 2009, of conspiracy; sex trafficking by force, fraud or coercion; and importation of aliens for purposes of prostitution.



  • OPA Press Releases

ut

U.S. Asks Federal Court to Shut Down Iowa Tax Preparers

The United States has sued a Clive, Iowa, couple to bar them from preparing federal tax returns for others. According to the government complaint, Jill Schwartz-Musin, her husband Howard Musin, and their business, SSC Services, prepare fraudulent federal income tax returns for small business owners.



  • OPA Press Releases

ut

Justice Department Seeks to Shut Down Sacramento Tax Preparation Firm

The United States has sued a Sacramento, Calif., tax preparer, Chris Elmer, his firm – Associated Tax Planners Inc. (ATP) – and several members of his family associated with ATP, seeking to bar them all permanently from the tax-preparation business. The civil injunction suit was filed in Sacramento with the U.S. District Court for the Eastern District of California.



  • OPA Press Releases

ut

U.S. Court Permanently Shuts Down Two Pennsylvania Tax Preparers

A federal judge in Pennsylvania has permanently barred Chalamar Muhammad and her husband, Curtis Muhammad, from preparing tax returns for others. Judge Harvey Bartle III of the U.S. District Court for the Eastern District of Pennsylvania entered the order of permanent injunction after the Coatesville, Pa., couple failed to defend against the government’s allegations.



  • OPA Press Releases

ut

UBS Enters into Deferred Prosecution Agreement

UBS AG, Switzerland’s largest bank, has entered into a deferred prosecution agreement on charges of conspiring to defraud the United States by impeding the Internal Revenue Service (IRS). As part of the deferred prosecution agreement and in an unprecedented move, UBS, based on an order by the Swiss Financial Markets Supervisory Authority (FINMA), has agreed to immediately provide the United States government with the identities of, and account information for, certain United States customers of UBS’s cross-border business.



  • OPA Press Releases

ut

Shipping Company, Chief Engineer and Second Engineer Indicted for Covering up Pollution

A federal grand jury in Newark, N.J., has returned an eight-count indictment charging a Liberian company that manages an oceangoing bulk carrier vessel, M/V Myron N, along with the ship’s chief engineer and second engineer for covering up discharges of oil-contaminated waste at sea.



  • OPA Press Releases

ut

Justice Department Sues Housing Authority in Wayne County, Ill., for Race Discrimination

The Department today filed a lawsuit against the Wayne County Housing Authority (WCHA), in Fairfield, Ill., as well as Jill Masterson and Danna Sutton, WCHA’s executive director and assistant director, respectively, alleging that they violated the Fair Housing Act when they tried to discourage a white couple from renting their property in Fairfield to an African-American woman.



  • OPA Press Releases

ut

United States Sues to Shut Down Florida Tax Return Preparer

The United States has filed suit against a Jacksonville, Fla., tax return preparer, seeking to shut down her business. According to the government complaint, Shirley Clark, who operates the Nichet Corp., has prepared at least 1,250 federal tax returns for her customers from 2004 until 2007 and, on those returns, Clark has claimed nearly $750,000 in fraudulent fuel tax credits.



  • OPA Press Releases

ut

Iraqi-Born Dutch Citizen Pleads Guilty to Terrorism Conspiracy Against Americans in Iraq

An Iraqi-born Dutch citizen today pleaded guilty to conspiring with others to murder Americans overseas, including by planting roadside bombs targeting U.S. soldiers in Fallujah, Iraq, and by demonstrating on video how these explosives would be detonated to destroy American vehicles and their occupants.



  • OPA Press Releases

ut

United States Files Suit Against Missouri-Based Pharmaceutical to Block Manufacturing and Shipping of Unapproved Drugs

The United States has filed a lawsuit to block KV Pharmaceutical Company, its subsidiaries, ETHEX Corp. and Ther-Rx Corp., and its principal officers from making and distributing adulterated and unapproved drugs. At the same time, KV agreed to the injunction in a consent decree.



  • OPA Press Releases

ut

U.S. Asks Courts in California & South Carolina to Shut Down Promoters of Allegedly Fraudulent $39.2 Million Tax Refund Scam

The United States has sued tax return preparers in Placerville, Calif., and Columbia, S.C., seeking to bar them from preparing federal tax returns for others. According to the government complaints in the two cases, Teresa Marty of Pollock Pines, Calif., and Winston Able of Blythewood, S.C., prepare federal income tax returns for their customers that claim fraudulent tax refunds.



  • OPA Press Releases

ut

Chief Engineer Pleads Guilty to Concealing Vessel Pollution

Carmelo Oria, a Spanish citizen, who was the Chief Engineer on the Cyprus-flagged M/T Nautilus, pleaded guilty today to using falsified records that concealed improper discharges of oil-contaminated bilge water from the M/T Nautilus.



  • OPA Press Releases

ut

Federal Court Shuts Down North Carolina Tax Preparer

A federal court has permanently barred Raymond A. Renfrow of Elm City, N.C., from preparing federal income tax returns for others. The U.S. District Court for the Eastern District of North Carolina entered the civil injunction order, which also stops Renfrow from promoting a tax fraud scheme that used sham trusts to falsely deduct customers’ non-deductible personal expenses.



  • OPA Press Releases