780,000 Doses of Bavarian Nordic Monkeypox Vaccine to be Shipped to US by End of July
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes as the disease pops up across the country.
Teva Asks US Supreme Court to Reverse Loss in “Skinny Label” Patent Suit, Says Decision is Competition-Killing for Generics
According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK and others argue that the practice is infringement because the generics are often prescribed off-label for the original drug’s indications. Teva has asked the US Supreme Court to reverse the decision, which ordered the company to pay GSK $235 million.
Two Labs Now Offers Medical Affairs and Communication Services
The pharma services company Two Labs is now offering medical affairs and communications services, according to a new press release. [...]
Royalty Pharma Buys Theravance to Get Royalties on GSK COPD Drug Trelegy Ellipta
Royalty Pharma has bought 85% of Theravance Biopharma to access royalty rights to its chronic obstructive pulmonary disease (COPD) drug [...]
FDA Commissioner Rob Califf Says Agency Will Advance New Evidence Generation System
During a Zoom event on Tuesday, June 12th, Food and Drug Administration (FDA) Commissioner Robert Califf told members of the [...]
Syndicated Report: Global Gene Therapy Market Projections 2022-2031
Despite the global pandemic, cancer was still the leading cause of death in 2020. This pressing therapeutic need underlies the growth projected by Kenneth Research in their new report entitled, “Global Gene Therapy Market.” The report predicts that the gene therapy market will earn around $6 billion USD from 2022-2031 with a CAGR of ~34%.
New York AG: Teva Was Aware of its Contribution to NY’s Opioid Epidemic, Contrary to Previous Testimony
New York Attorney General Letitia James has leveled accusations at the Israeli drugmaker Teva that it misrepresented its role in the state’s opioid crisis. The company previously distanced itself from its US operations, but new information suggests that Teva was directly in charge of the unit. According to James, Teva obfuscated its connections to its US operations through a series of shell companies to shuffle the money into offshore accounts.
On-Demand Webinar: Accelerating Patient Recruitment Post-COVID-19
The COVID-19 pandemic changed the playing field of clinical trial patient recruitment permanently. As the clinical research industry moves towards [...]
ICER Announces Initiative to Develop Health Equity-Targeted HTA Practices
Health technology assessment (HTA) agencies are primarily focused on efficacy and safety of a therapeutic on a general population. A [...]
New Study Will Investigate Effect of Racial Inequity on Caregiver Resources and Health Outcomes
The COVID-19 pandemic has brought the public spotlight on racial disparities of health outcomes, but little research has been done [...]
A Health Podyssey Podcast: Jane Zhu Gets Spooky About Phantom Providers
Mental healthcare is hard for many patients to access, especially those on Medicaid. In the newest episode of A Health [...]
How Decentralized Clinical Trials Can Center Patient Care
The COVID-19 pandemic drove decentralized care models to new prominence, allowing patients to safely access care from home through telehealth. [...]
Small Startup TrueBinding Raises $100 Million for Stroke and Alzheimer’s Disease Drug
The secretive startup TrueBinding announced that it raised $100 million in investments for its experimental antibody drug for Alzheimer’s Disease and stroke. The press release was muted, just over 30 words. TrueBinding has not revealed who the investor is, the third to fund the company since 2019.
China Announces Price Cuts, Hitting Astrazeneca, Pfizer, and Novartis’s Profits
China’s latest round of price cuts dinged profits of many major pharma companies, especially Astrazeneca, Pfizer, and Novartis. The companies [...]
Using Technology and Supplemental Services to Improve Health Outcomes in Medicare Advantage Members
Medicare Advantage (MA) plans are increasingly focusing on tackling health inequities. Social determinants of health (SDOH) like income, food, shelter, [...]
HRA Pharma Files FDA Application for First Over-the-Counter Oral Contraceptive
HRA Pharma has submitted its application for the US’s first over-the-counter (OTC) birth control pill. The company, a subsidiary of [...]
Former COO of Theranos Found Guilty of Fraud
Ramesh “Sunny” Balwani, the former COO of the notorious defunct biotech Theranos, has been found guilty on 12 charges of [...]
US Supreme Court Decision on Abortion Raises Concerns Over Real-World Evidence
The US Supreme Court’s ruling on abortion has brought new concerns to light regarding the use of real-world evidence (RWE). [...]
Webinar: Democrats’ Last Chance for Drug Pricing Reform?
Drug pricing reform is a key priority in the US Congress, with politicians from across the aisle working together in [...]
Labcorp Ramps Up Monkeypox Testing Capabilities
As monkeypox continues to spread across the world, Labcorp has announced that it is increasing its testing capabilities at its [...]
US Senate Finance Committee Report Targets Trump Tax Laws that Benefited AbbVie
Democrats in the US Senate Finance Committee has called out the tax practices of AbbVie. The company and others used [...]
Sinopharm Looking to Acquire DNA Synthesis Biotech for $1B
Sinopharm, a Chinese pharma company responsible for the country’s inactivated COVID-19 vaccine, is considering purchasing the China-based DNA synthesis firm [...]
Biden Signs Executive Order on Abortion Rights
US President Joe Biden has signed an executive order meant to curtail the wave of abortion bans that have passed [...]
Webinar: Modernize Your Patient Support Programs (PSPs) to Ensure a Seamless Patient Experience
Patient support programs (PSPs) have historically underdelivered for patients, in part because they fail to include patients in the development [...]
Potential FTC Crackdown Looms Large over Merck’s Potential Seagen Acquisition
The threat of antitrust intervention weighs heavily over reports that Merck is inching closer to its potential acquisition of Seagen. [...]
