In what was a decision that was four months ahead of schedule, the FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu. This is the first therapy targeted to treat unresectable or metastatic breast cancer expressing low levels of HER2, a brand-new category that was once part of the HER2-negative group.

On June 21st, Sun Pharma started a voluntary recall of 50,680 vials of testosterone cypionate injection because of water leakage at a plant. Glenmark’s recall is for 98,307 packs of mometasone furoate topical solution, a corticosteroid lotion which treats skin conditions

In February 2021, Azurity Pharmaceuticals acquired three drugs from Eton Pharmaceutical’s neurology portfolio. To date, two of those three drugs have now been approved by the FDA. The most recent is Zonisade, the first authorized liquid medication to treat epilepsy in patients 16 years and older. The approval was delayed due to COVID travel restrictions which prevented a manufacturing site inspection in 2021.

AstraZeneca has announced a $1.28B plan to purchase TeneoTwo, a U.S. oncology firm. AstraZeneca said the purchase will be focused on a molecule made by the company that is designed to encourage the body's immune system to target and kill cancer cells.

Lumos Diagnostics, a leader in rapid point-of-care (POC) diagnostic technologies, has announced that they have appointed Doug Ward to serve as CEO. Doug is a highly experienced diagnostics executive.

With $24 billion in net income, Novartis was unexpectedly the most profitable pharma company in 2021, beating Pfizer and J&J, which recorded $22 billion and $21 billion, respectively. While Novartis did improve its profit margins as a percentage of sales, it was one special item that helped nearly triple the Swiss pharma’s net profit.

Sanofi has moved into its new HQ location in Cambridge, MA. The new office space has two 900,000 square foot buildings that will house around 2,500 employees. Plans for the location started in December 2018 and were not swayed by the COVID-19 pandemic. Sanofi also put environmental sustainability at the forefront when designing the new facility.

After a few years of running a profitable company, you’re ready to expand. You have a loyal customer base, a strong team, and more demand than you can handle. What is the best way to expand your business and what should you consider as you prepare for rapid growth? Let these tips guide your business’s growth.

It’s not a surprise that 4 of the top 20 drugs in worldwide sales in 2021 were COVID-related medications. Pfizer and BioNTech’s vaccine topped the list generating $36.8 billion in sales. Other notable movers were Dupixent (Regeneron and Sanofi’s eczema treatment) with a 55% increase in sales, Darzalex (Johnson and Johnson’s cancer treatment) had a 43% increase in sales and Trikafta (Vertex’s cystic fibrosis drug) had a 46 % increase in sales.

AES Clean Technology is celebrating! The provider of high-performance cleanroom facilities within the pharmaceutical and biopharmaceutical industry has just received news that they produced three of this year’s winners for Facility of the Year by The International Society for Pharmaceutical Engineering (ISPE). This means AES was a cleanroom partner to all of the North American award-winning and honorable mention facilities.

Jorge Gomez, former CFO at Moderna was let go after one day on the job and will need to return his $700,000 severance pay if he is found guilty of wrongdoing with his former employer.

ADC Therapeutics has announced that co-founder Chris Martin is stepping away from his role as CEO of the commercial-stage biotechnology company. Joining the company is Ameet Mallik, formerly Head of Oncology at Novartis and CEO of Rafel Holdings.

Over the upcoming weeks, the Fierce Biotech and Fierce Pharma teams will profile influential CEOs scientists, entrepreneurs, and regulatory experts in the biopharma world.

Viatrus, formerly Mylan Pharmaceuticals has sold its former manufacturing plant in Morgantown, West Virginia to West Virginia University for $1. The former factory, which once housed more than 1,400 employees and was closed last summer.

Data analytics can have a profound effect on how a business operates, and they play a large role in the growth strategies that businesses employ. Currently, only about 50% of businesses are making use of data analytics, but that number will only continue to grow in today's technology-driven society. Here are just a few of the benefits your business can expect to see once you begin making data analytics part of your business operations.

Less than three years after launching its breast cancer drug Piqray, Novartis has received an FDA approval for the treatment in a rare condition PROS. This drug, named Vijoice, a PI3K inhibitor to treat PIK3CA-related overgrowth spectrum (PROS), an umbrella term for the rare condition that causes blood vessel abnormalities and overgrowth of tissue that can present in a variety of ways.

Data thieves can use SMS messages to steal your personal information. Watch out for these warning signs.

According to the Pew Research Center, 21 percent of Americans say they regularly wear smartwatches or fitness trackers. As companies look to save money whether it is preventing workplace injuries or cutting insurance costs by employees making healthier lifestyle changes they are investigating the possibilities of how wearable devices can be used in the workplace.

On Monday, Pfizer issued a voluntary recall of its blood pressure drug Accuretic along with two of its generic hypertension treatments distributed by Greenstone in the United States because of the presence of cancer-causing agents. Earlier in the month, they recalled two of its blood pressure medicines in Canada.

In a new national Cologuard, Katie Couric talks about losing her first husband, Jay Monahan to colon cancer at the age of 42 in an effort to encourage people age 45 or older to get screened for colon cancer.