Search Results for “EC” – Page 79 – media

AbbVie, AstraZeneca, Boehringer and more face FTC’s ire for ‘improper’ patent listings

Only two months after the Federal Trade Commission (FTC) said it was eyeing a crackdown on “improper” patents listed at the FDA, the agency has filed a challenge against more than 100 patents in the agency’s Orange Book. The patents cover drugs marketed by the likes of AbbVie, AstraZeneca, Boehringer Ingelheim, GSK and Teva, among other companies, the FTC said in a Tuesday release. In all, the commission has sent letters to 10 companies notifying them of the patent disputes. The FTC argues “improper” listings in the FDA’s Orange Book—the registry of patents on approved medicines—can throw up hurdles to competition in the drug industry. Specifically, improper patents can trigger regulatory delays for would-be generics challengers and throw up legal hurdles for generics players, the commission says. Some of the medicines targeted in this crackdown include AbbVie’s Restasis and Viatris’ EpiPen autoinjectors. As the antitrust agency points out, FDA regulations ...
- Source: drugdu
- 91
- November 9, 2023
Align Technology makes $100M open market stock repurchase

BY SEAN WHOOLEY Align Technology (Nasdaq:ALGN) announced today that it plans to repurchase $100 million of its own common stock. Tempe, Arizona-based Align Technology’s open market repurchase falls under its $1 billion stock repurchase program. The company’s board approved the program in January 2023. Align Technology executed a $250 million repurchase in February of this year with Citibank. Last month, the company triggered another $250 million repurchase in an accelerated program. As with other repurchase efforts, Align Technology President and CEO Joe Hogan intends to personally purchase $1 million in common stock. He did the same in the company’s accelerated program last month. The company expects to complete the repurchases by mid-December 2023, funding them with cash on hand. As of Sept. 30, 2023, it had approximately 76.6 million shares outstanding with $1.3 billion in cash on hand. “Invisalign is the most trusted brand in the Orthodontic industry globally and ...
- Source: drugdu
- 132
- November 8, 2023
【EXPERT Q&A】As a medical trade professional, how can one effectively manage a B2B platform account?

Drugdu.com expert’s response: As a medical trade professional, effectively operating a B2B platform account is key to achieving good promotional results. Here are some suggestions to help you better manage and promote your B2B account: 1.Complete and professional company profile: Ensure your company profile (including company introduction, contact details, licenses, qualifications, etc.) is complete and up-to-date. High-quality images and clear product descriptions will enhance the appeal of your company and products. 2.Continuous product updates: Regularly update your product catalog, ensuring each product description is accurate and detailed. Provide key information such as product images, specifications, prices, and MOQ (Minimum Order Quantity). 3.Timely responses: For B2B buyers, a quick and professional response is crucial. Ensure you or your team can reply to buyer inquiries promptly. 4.Customer reviews and feedback: Encourage satisfied customers to provide positive feedback, which can increase trust from other potential buyers. For any negative feedback, respond promptly and attempt ...
- Source: drugdu
- 335
- November 8, 2023
Pfizer’s Litfulo approved by MHRA for adults and adolescents with alopecia areata

Pfizer’s Litfulo (ritlecitinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat severe alopecia areata in patients aged 12 years and older. Affecting approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face or body. The condition can develop at any age and nearly 20% of patients are diagnosed before the age of 18. Litfulo, which is a one-daily oral kinase inhibitor, works by blocking the activity of enzymes in the body involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata. The MHRA’s decision on the drug was supported by positive results from the phase 2b/3 ALLEGRO trial, which evaluated Litfulo in patients aged 12 years and older with 50% or more scalp hair loss, including those with total scalp and body ...
- Source: drugdu
- 107
- November 5, 2023
Novavax’s XBB.1.5-adapted COVID-19 vaccine receives EC approval

Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older. The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response. The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. Based on previous recommendations by ...
- Source: drugdu
- 204
- November 3, 2023
BioMarin’s longtime CEO Jean-Jacques Bienaimé hands the reins to Genentech’s Alexander Hardy

After 18 years at the helm, BioMarin’s CEO Jean-Jacques Bienaimé is hanging up the gloves. But he won’t be leaving the company without capable hands. Genentech CEO Alexander Hardy is leaving his current post—effective immediately—and will replace Bienaimé upon the BioMarin chief’s retirement on December 1. The transition comes after a “multi-year succession planning process” and a comprehensive search by BioMarin’s board, the company’s lead independent director Richard A. Meir said in a Wednesday statement. The Genentech CEO fit the bill as a candidate with “experience driving commercial growth and operational excellence,” Meier, who will now become chair of BioMarin’s board of directors, added. When Bienaimé took over BioMarin in 2005, the company was collecting some $26 million annually from its one marketed product, enzyme replacement therapy Naglazyme. Now, thanks to dwarfism med Voxzogo and hemophilia A gene therapy Roctavian, BioMarin recently turned a corner into profitability after many years ...
- Source: drugdu
- 99
- November 3, 2023
Merck’s Keytruda nabs FDA nod in biliary tract cancer, catching up with AstraZeneca’s Imfinzi

After AstraZeneca’s Imfinzi last year claimed new territory in the biliary tract cancer space, Merck’s Keytruda has hit the scene with an FDA nod to match its rival. The approval in locally advanced unresectable or metastatic biliary tract cancer, combined with the chemotherapies gemcitabine and cisplatin, marks Keytruda’s sixth U.S. nod in gastrointestinal cancer, Merck said. The FDA based the approval on data from the company’s Phase 3 KEYNOTE-966 trial, which showed that the Keytruda-chemo combo extended patients’ survival time compared with chemotherapy alone. In the study, patients in the treatment arm lived a median 12.7 months, compared to 10.9 months for those on solo chemo. The Keytruda-chemo combo reduced the risk of death by 17% over solo chemotherapy, researchers found. In addition, Keytruda-treated patients experienced a longer median duration of response at 9.7 months, compared with 6.9 months for solo chemotherapy. Merck is “proud” to offer the new treatment ...
- Source: drugdu
- 97
- November 3, 2023
Sarepta’s Elevidys fails on primary endpoint, but executives see path to wider DMD approval anyway

After Sarepta Therapeutics overcame several regulatory hurdles to finally win FDA approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys, the company now faces the prospect of more FDA scrutiny because a pivotal study on the drug has failed on the primary endpoint. The endpoint, a measure of motor function called the North Star Ambulatory Assessment (NSAA), failed to reach statistical significance in the phase 3 EMBARK study, Sarepta said in a Monday release. Despite this result, Sarepta Chief Scientific Officer Louise Rodino-Klapac, Ph.D., touted “clinically meaningful” effects seen across the trial’s secondary endpoints. Speaking on a Monday conference call, Rodino-Klapac said Sarepta plans to file for a label expansion to treat “all DMD patients” and to convert the drug’s accelerated approval into a traditional nod. Sarepta CEO Doug Ingram said the study “met the standard” to show “evidence of effectiveness.” He added that the results show that the ...
- Source: drugdu
- 95
- November 2, 2023
Five pharma firms fined €13.4m over EC’s cartel investigation

Five pharmaceutical companies have been fined €13.4m ($14.1m) by the European Commission as part of an antitrust cartel settlement revolving around a key ingredient for the antispasmodic drug, Buscopan. The European Commission (EC) has confirmed that Alkaloids of Australia, Alkaloids Corporation, Boehringer, Linnea, and Transo-Pharm all admitted involvement in the cartel and agreed to settle the investigation with the fine. A sixth company, C2 Pharma, was also involved in the plot but was not fined as it revealed the cartel to the EC under the leniency programme. The EC investigation revolved around N-butylbromide scopolamine/ hyoscine (SNBB), an important input material used to produce the abdominal antispasmodic drug, Buscopan, as well as its generic versions. The investigation found that the six companies had coordinated and agreed to fix the minimum sales price of SNBB to customers, as well as allocate quotas. Additionally, the six companies exchanged commercially sensitive information. In a ...
- Source: https://www.pharmaceutical-technology.com/news/five-pharma-firms-fined-e13-4-million-over-ecs-cartel-investigation/
- 130
- October 30, 2023
PTC inks Royalty deal worth up to $1.5B on Genentech-partnered SMA drug Evrysdi

Amid a cost-cutting drive and a looming commercial threat in Europe, PTC Therapeutics is raising cash in a new royalty deal. In an agreement with Royalty Pharma worth up to $1.5 billion, PTC agreed to sell 67% of its royalty interest in the Roche-partnered spinal muscular atrophy drug Evrysdi. The deal includes an upfront payment of $1 billion, plus the option for PTC to sell its remaining royalty interest down the line for up to $500 million. As it stands, PTC will hold onto approximately 19% of its royalty interest on the drug, which it licensed to Roche’s Genentech in 2011. The deal gives PTC “added financial flexibility as we pursue our strategic objectives,” PTC’s chief Matthew Klein, M.D., said in a statement. The company recently disclosed more than 300 layoffs in New Jersey as its Duchenne muscular dystrophy drug Translarna faces a potential market withdrawal in Europe. PTC says it will use the capital to pay off its debt from Blackstone Life Sciences, which invested up ...
- Source: https://www.reuters.com/business/healthcare-pharmaceuticals/royalty-pharma-pay-1-bln-roches-sma-drug-royalties-2023-10-19/
- 103
- October 30, 2023

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