Search Results for “acquisition” – Page 33 – media

FDA approves Duchenne gene therapy with hefty $3.2m price tag

Children with a confirmed mutation of the DMD gene – responsible for causing Duchenne muscular dystrophy (DMD) – are closer to receiving the first gene therapy for the disease after the US Food and Drug Administration (FDA) approved Sarepta’s highly anticipated Elevidys (delandistrogene moxeparvovec-rokl). On a conference call following the approval, Sarepta CEO Douglas Ingram said the company has set the wholesale acquisition cost of Elevidys at $3.2m. After a narrow US Food and Drug Administration Advisory Committee (AdCom) panel vote and a delay to the Prescription Drug User Fee Act (PDUFA) date, Sarepta’s therapy crossed the approval finish line. The decision, which came through the accelerated approval pathway, is for children ages four to five with a confirmed mutation in the DMD gene. As per Sarepta, Elevidys’ price is below the cost-effectiveness range, which is estimated to be between $5m and $13m. Sarepta’s adeno-associated virus (AAV) mediated therapy delivers ...
- Source: drugdu
- 100
- June 25, 2023
Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonide) and Cetraxal (ciprofloxacin) all exchange hands to Blue Water’s ownership. All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m. Blue Water’s major purchasing agreement comes at a time when pharma mergers and acquisitions are beginning to pick up after a slow start to 2023. Included in the agreement are the patents related to Zontivity – a medication for patients with ...
- Source: drugdu
- 106
- June 17, 2023
With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company’s mantra to be ‘aggressive’

Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
- Source: drugdu
- 114
- June 15, 2023
Amgen, Horizon blast FTC’s ‘baseless assumptions’ in response to antitrust lawsuit

As Amgen and Horizon pursue their $27.8 billion merger, they’re facing off against the U.S. Federal Trade Commission and its lawsuit to block the deal. Now, in response to the complaint, the companies have called the lawsuit “as misguided as it is unprecedented.”The lawsuit, filed in May, seeks an injunction against the deal on antitrust grounds. Specially, the FTC argued that Amgen could pressure insurers and pharmacy benefit managers to accept higher prices for Horizon’s thyroid eye disease drug Tepezza and gout med Krystexxa based on the company’s “history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals.” Amgen and Horizon find these allegations “far too speculative” to make the case of probable harm, the two companies said in their response, filed Friday in federal court. The FTC expects Amgen to bundle its rebates in the event of future competition to Horizon’s products, which the ...
- Source: drugdu
- 111
- June 15, 2023
After Albireo buyout, Ipsen’s Bylvay picks up new FDA-approved use

After Ipsen made a splash at this year’s J.P. Morgan Healthcare Conference by scooping up liver disease specialist Albireo Pharma, the centerpiece of the buyout, Bylvay, has won a coveted label expansion.First approved by the FDA to treat cholestatic pruritus from progressive familial intrahepatic cholestasis, Bylvay has now won an FDA approval in another liver disease. Specifically, the drug can now treat cholestatic pruritus due to Alagille syndrome in patients 12 months of age and older. Cholestatic pruritus is the intense itching that afflicts patients with the diseases. A once-daily ileal bile acid transport inhibitor (IBATi), Bylvay will challenge Mirum Pharmaceuticals’ Livmarli in this disease. Livmarli won an FDA approval in Allagile syndrome back in 2021 and generated $29 million during the first quarter of 2023. Analysts with Evercore ISI have previously put a $1 billion peak sales target on Mirum’s rival drug. Bylvay’s new approval is based on results ...
- Source: drugdu
- 115
- June 15, 2023
Cosette acquires worldwide rights to Endoceutics’ Intraros prescription drug

Cosette Pharmaceuticals has acquired the worldwide rights to prescription drug, Intraros, from Endorecherche’s subsidiary Endoceutics. The transaction includes 108 issued and pending patents globally with the latest expiring this year including three Orange Book listed patents. The acquisition will expedite Cosette’s women’s health portfolio, with a commercial stage product that is patent protected. At present, Intrarosa is offered in almost all major markets, including the UK, the US, Canada, EU and Israel through local partners such as Tecnimede, Avia, Theramex, Lupin, Labatec, Dexcel, Lacer, Lee’s Pharma, and Valenta. It is expected to be launched in Asian market in 2025. Cosette Pharmaceuticals president and CEO Apurva Saraf said: “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation. “In partnership with MSH Pharma, Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa. We look forward to expanding ...
- Source: drugdu
- 107
- June 13, 2023
’ Seagen CEO talks about his next stop, Pfizer deal and the ADC landscape

David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
- Source: drugdu
- 187
- June 10, 2023
Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
- Source: drugdu
- 131
- June 8, 2023
AZ notches postmarket win for bleeding reversal agent Andexxa, plans to seek full approval

After a postmarketing study of AstraZeneca’s bleeding reversal agent Andexxa met its primary endpoint earlier than planned, AZ is ending the study at the recommendation of a data monitoring board.In the study, investigators tested Andexxa versus standard care in more than 450 patients with intracranial bleeding who have received blood thinners called factor Xa inhibitors. Those who received the AstraZeneca drug experienced superior hemostatic efficacy compared with the control arm, AZ said in a Monday release. Hemostatic efficacy is a measure of the body’s ability to stop the flow of life-threatening brain bleeds. “We are proud to offer the first and only approved treatment to specifically reverse FXa inhibitor activity and help achieve haemostasis, providing an effective and reliable treatment when immediate care is required,” AZ’s executive vice president of biopharmaceuticals R&D, Mene Pangalos, Ph.D., said in a statement. Now, the company will look to convert Andexxa’s speedy approvals in ...
- Source: drugdu
- 120
- June 7, 2023
Bristol Myers’ $4B plan for Reblozyl takes shape in blood cancer anemia—with one caveat

Bristol Myers Squibb’s Reblozyl could be an effective initial treatment for anemia patients who are suffering from a group of blood cancers called myelodysplastic syndromes (MDS) and are at a relatively lower risk of progression. That’s the conclusion reached by Olatoyosi Odenike, M.D., from the University of Chicago Medical Center, after she reviewed data from the phase 3 COMMANDS trial that are slated to be presented at the 2023 American Society of Clinical Oncology (ASCO) annual meeting. Odenike is an invited ASCO expert and an opinion leader in the MDS field. The COMMANDS trial is the first study in decades that has shown a benefit for a new agent against erythropoiesis-stimulating agents (ESAs) in low- to intermediate-risk MDS, Noah Berkowitz, M.D., Ph.D., senior vice president of hematology development at BMS, said in an interview with Fierce Pharma. If the FDA eventually agrees with Odenike’s finding, Reblozyl could move from behind ...
- Source: drugdu
- 262
- May 29, 2023

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