Search Results for “acquisition” – Page 32 – media

FDA Greenlights First Over-the-Counter Birth Control Pill

Women of all ages in America will soon have access to a birth control pill that does not require a prescription, after the US Food and Drug Administration (FDA) approved Perrigo’s Opill (norgestrel). The progestin-only pill will be the first contraceptive medication in the US that can be bought from the same aisle as paracetamol or toothpaste. Marketed as Opill, Perrigo gained control of the drug after an acquisition of HRA Pharma in 2022. In a statement, the FDA said that the non-prescription availability of the medicine will help reduce barriers to accessing contraceptives. The once-a-day pill should be available early next year, but its pricing remains to be announced. The approval comes amidst a widening cultural divide regarding women’s health rights. Many US states have introduced laws that ban abortion after the US Supreme Court overturned Roe v Wade. Opill’s availability opens accessibility avenues to women’s ...
- Source: drugdu
- 131
- July 15, 2023
Urotronic Wins FDA Approval to challenge Boston Scientific, Teleflex for Prostate Market

Dive Brief The U.S. Food and Drug Administration has approved Urotronic’s minimally invasive surgical treatment of symptoms linked to benign prostatic hyperplasia (BPH), the company announced Tuesday. BPH is defined by the expansion of the prostate. As the organ grows, it can cause changes in the bladder that result in lower urinary tract symptoms such as leaking urine. Urotronic’s newly approved Optilume BPH catheter system is designed to tackle the symptoms through mechanical dilation and the delivery of paclitaxel to stop the problem from recurring. Dive Insight Researchers studied the use of balloon dilation in BPH in the 1990s, but the technique failed to provide long-term benefits. Urotronic has tried to address that problem by pairing the immediate symptomatic relief provided by balloon dilation with localized delivery of paclitaxel, a drug that is already widely used in cardiovascular devices to prevent blood vessels from narrowing after ...
- Source: drugdu
- 120
- July 15, 2023
NVIDIA Doubles Down on AI Drug Discovery with $50M Recursion Investment

Clinical-stage biotech Recursion continues to go from strength to strength. After its recent acquisition of Cyclica and Valence, the company announced a partnership with—and $50 million investment from—NVIDIA on Wednesday. Under the agreement, the tech giant is giving Recursion a $50 million private investment in public equity. The two companies are looking to accelerate the development of Recursion’s AI foundation models to help the biopharma industry create improved patient therapies more quickly. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space,” Recursion CEO Chris Gibson said in a statement. Recursion has built a massive biological and chemical database via its Recursion OS, which exceeds 23 petabytes and has three trillion searchable compound and gene relationships. The company has been training machine-learning algorithms on this dataset to tackle the complex ...
- Source: drugdu
- 128
- July 14, 2023
Coloplast to Pay $1.2B Upfront to Buy Fish Skin Wound Care Business Kerecis

Dive Brief Danish medical device maker Coloplast has agreed to buy Iceland-based wound care company Kerecis for $1.2 billion upfront, giving it control of a business that is expected to grow sales by 50% this year, the companies announced Friday. Kerecis sells a wound care product based on fish skin. Launched in 2016, the product drove sales at Kerecis to 510 million Danish kroner ($74.5 million) last year, and more growth is forecast for this year. Coloplast, which will run Kerecis as a standalone business unit, increased its long-term organic growth guidance by one percentage point, bumping the target up to the 8% to 10% range. Dive Insight Coloplast is already a player in the wound care segment. With a portfolio that features the Biatain foam dressing, the Danish medtech company grew wound care sales by 12% in its second quarter. Backorders limited growth in the quarter, ...
- Source: drugdu
- 140
- July 12, 2023
Clinics ration supplies as cancer drug shortages proliferate

Drug shortages have been in the news for several years, but they worsened during the Covid-19 pandemic, and several pharmacy, regulatory, and physician organisations, in the US and Europe, have recently issued alerts in response. In May, the American Cancer Society declared that chemotherapy drugs were among the top-five drug classes affected by shortages, and numerous oncology medications are currently in short supply according to data from the US Food and Drug Administration (FDA). “The shortages of oncology drugs are primarily in the generic drug market,” says Dr. Kevin Shulman, a professor of medicine and clinical hospitalist at the Clinical Excellence Research Center at Stanford University. There is no financial incentive for big pharma to manufacture older generic medications that are critical to the treatment of several common cancers and very few companies invest in doing so, says Dr. Kristen Rice, medical oncologist with a practice in San Diego, California. ...
- Source: drugdu
- 102
- July 7, 2023
Former Alexion VP, 4 others find their ‘goose’ is cooked with SEC insider trading charges

The Securities and Exchange Commission (SEC) has revealed insider trading charges against five—including former Alexion Vice President Joseph Dupont and a Massachusetts police chief—who allegedly took advantage of prior knowledge of Alexion’s 2020 acquisition of Portola Pharmaceuticals. Dupont, 44, of Rehoboth, Massachusetts, was the head of go-to market transformation and business operations for Alexion until April of this year. He is alleged to have tipped off his childhood friend Shawn Cronin, the police chief of Dighton, Massachusetts, about the company’s intent to buy out Portola. Cronin, 43, is alleged to have passed the information to two other friends, one of whom told Paul Feldman, 48, of the deal. In all, four bought stock in Portola, which netted them more than $2.3 million, including $1.73 million to Feldman, the SEC said. One of the friends, Slava Kaplan, 45, who made $472,000 from his trades, texted Feldman in Russian: “Let’s hope our ...
- Source: drugdu
- 111
- July 5, 2023
BioMarin Wins FDA Approval for First Gene Therapy for Hemophilia A

By Tristan Manalac Pictured: BioMarin headquarters/iStock, Michael Vi The FDA has approved BioMarin Pharmaceutical’s valoctocogene roxaparvovec-rvox, to be marketed as Roctavian in the U.S., for the treatment of adult patients with severe hemophilia A, the company announced Thursday. Roctavian, a one-time single-dose infusion, is authorized for use only in adults without antibodies against the adeno-associated virus serotype 5 (AAV5), as determined by an FDA-approved test. It is also the first gene therapy approved for hemophilia A, according to BioMarin’s news release. In an investor call Thursday afternoon, BioMarin Chief Commercial Officer Jeff Ajer said that “the product profile of Roctavian presents tremendous value to patients, including bleed control, good safety profile and freedom from the burden of chronic therapy.” Roctavian is “priced at a wholesale acquisition cost, or WAC, that equates to $2.9 million for the typical patient for this one-time, single-dose treatment,” Ajer said. Hemophilia A is an inherited ...
- Source: drugdu
- 110
- July 4, 2023
BioMarin’s hemophilia gene therapy Roctavian lands FDA nod with ‘glimmers’ of enthusiasm among doctors

After an initial rejection in 2020 and a review delay earlier this year, BioMarin’s Roctavian has finally got the FDA go-ahead to introduce a gene therapy for a not-so-rare disorder.The FDA has cleared Roctavian as a one-time therapy for adults with severe hemophilia A, BioMarin said Thursday. The news comes seven months after the FDA greenlighted CSL Behring’s hemophilia B gene therapy Hemgenix, which bears a list price of $3.5 million and is currently the most expensive drug in the world. BioMarin is pricing Roctavian at a wholesale acquisition cost of $2.9 million, BioMarin’s chief commercial officer Jeff Ajer said during a call Thursday. It’s also setting up an outcomes-based warranty program. The warranty will reimburse government and commercial payers up to the full cost if Roctavian doesn’t live up to its treatment expectations. Partial reimbursement will be granted if an individual loses response to the therapy in the first four ...
- Source: drugdu
- 105
- July 1, 2023
Bayer’s BlueRock Reports Positive Early Data for Parkinson’s Stem Cell Therapy

By Heather McKenzie https://www.biospace.com/ Bayer logo on a building under blue sky/Getty Images, Kena Betancur/VIEWpress/Corbis Bayer subsidiary BlueRock Therapeutics has taken another next step in its bid to bring a potentially curative therapy to Parkinson’s disease patients. Wednesday, the companies reported that bemdaneprocel, a stem cell therapy, was well tolerated with no major side effects in a Phase I study. Topline data from the trial of 12 patients also showed feasibility of transplantation and evidence that the cells survived and engrafted in the brain after one year, satisfying the study’s secondary endpoints. Full data will be presented in August at the 2023 International Congress on Parkinson’s Disease and Movement Disorders in Copenhagen. The therapy, also known as BRT-DA01, is the first to show positive results in a Phase I study for Parkinson’s, according to Bayer. Bemdaneprocel consists of dopamine-producing neurons derived from pluripotent stem cells. In Parkinson’s disease, patients lose ...
- Source: drugdu
- 116
- June 30, 2023
States Back FTC in Lawsuit Seeking to Block Amgen-Horizon Deal

Pictured: FTC sign on a wall/iStock Six U.S. states are joining the Federal Trade Commission’s lawsuit seeking to block Amgen’s $27.8 billion buyout of rare disease biotech Horizon Therapeutics, Reuters reported on Thursday. The acquisition “would allow Amgen to monopolize the market for certain crucial medications,” which would make these treatments less affordable and accessible to patients, Illinois Attorney General Kwame Raoul said in a statement. Illinois is one of the states joining the FTC’s lawsuit, along with California, Minnesota, New York, Washington and Wisconsin. In the amended lawsuit, the six states and the FTC are asking the District Court of the Northern District of Illinois to issue a preliminary injunction against the Amgen-Horizon deal while the Commission prepares an administrative complaint, and until decisions have been made about the complaint. The plaintiffs are also seeking a temporary restraining order against the acquisition and any other related transactions. “When drug ...
- Source: drugdu
- 117
- June 25, 2023

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