PharmaFocus Today – Page 340 – media

Amgen, J&J ink patent settlement

After the recent high-profile loss of exclusivity for AbbVie’s megablockbuster immunology drug Humira, industry watchers’ eyes moved to Johnson & Johnson’s Stelara as one of the next major drugs expected to face biosim competition. Tuesday, the industry got more information about when exactly that biosimilar clash might occur. In J&J’s patent case over Amgen’s proposed biosimilar to J&J’s Stelara, the companies have settled, according to a Tuesday filing in Delaware federal court. An Amgen spokesperson told Reuters the deal will allow the company to launch its Stelara biosimilar “no later than January 1st, 2025.” With that, the market exclusivity clock is ticking on J&J’s biggest drug by sales. Last year, the medicine pulled down $9.72 billion across its range of indications, including plaque psoriasis, psoriatic arthritis and Crohn’s disease. Amgen has yet to win FDA approval for its proposed biosimilar. The company filed its biosim application last November, so the ...
- Source: drugdu
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- May 25, 2023
Ironwood to Pay $1B to Acquire VectivBio, Late-Stage Digestive Therapy

By Jef Akst Pictured: Illustration of a human body with the intestines highlighted/iStock, Rasi Bhadramani At $17 per share, Ironwood Pharmaceuticals has agreed to buy VectivBio for around $1 billion in a cash deal. In doing so, the Boston-based company, which already markets Linzess for irritable bowel syndrome and constipation with AbbVie, will expand its gastrointestinal drug portfolio. The Swiss biotech’s most advanced product is apraglutide, being developed for short bowel syndrome with intestinal failure (SBS-IF) that affects some 18,000 adult patients in the U.S., Europe and Japan, according to the Ironwood press release. People with the disorder are unable to absorb adequate nutrition from their food, leading to impaired quality of life and sometimes death. Takeda Pharmaceuticals has an approved drug, Gattex, that aims to treat short bowel syndrome but requires daily injections. Apraglutide is being tested in a Phase III study involving weekly injections. “There’s certainly challenges with ...
- Source: drugdu
- 136
- May 24, 2023
Pfizer oral weight loss drug may be as effective as Ozempic injection by Novo Nordisk, study says

An oral drug made by Pfizer causes a similar amount of weight loss as rival Novo Nordisk’s blockbuster injection Ozempic, according to a peer-reviewed study of phase 2 clinical trial results released Monday. The results were presented at a medical conference late last year, and did not compare Pfizer’s drug with Ozempic or other weight loss medications. JAMA Network only now is releasing a peer-reviewed study. Pfizer’s trial followed 411 adults with Type 2 diabetes who either took the company’s pill, danuglipron, twice a day or a placebo. Body weight was “statistically significantly reduced” after patients took either 120-milligram or 80-milligram versions of danuglipron for 16 weeks, the study found. Patients who took a 120-milligram version lost around 10 pounds on average over that time period, the study found. Pfizer’s drug could offer an advantage as an oral treatment option rather than a frequent injection. The study results also suggest ...
- Source: drugdu
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- May 24, 2023
Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market

Dive Brief: Beta Bionics said it received 510(k) clearance from the Food and Drug Administration for its automated insulin dosing (AID) system, teeing it up to challenge Insulet, Medtronic and Tandem Diabetes Care for the Type 1 diabetes market. The system, iLet Bionic Pancreas, features an insulin pump and dosing software that combine with the Dexcom G6 continuous glucose monitor to automate the calculation and delivery of insulin doses. Beta Bionics, which showed the AID system beat standard of care last year, has differentiated its device through simplification and automation, limiting the information users need to input and preventing them from modifying their insulin doses. Dive Insight: The launch of iLet Bionic Pancreas may serve as a test of whether people with Type 1 diabetes are willing to almost totally cede control of their insulin dosing to an algorithm. Users of existing hybrid closed-loop systems enter information such as basal ...
- Source: drugdu
- 114
- May 24, 2023
A clever way to detect narcissism

A team of psychologists at the University of Helsinki, working with a colleague from Millsaps College, has discovered, via experimentation, a clever, new way to detect narcissism in a person. In their study, reported in the journal Psychophysiology, the group measured physical responses to certain stimuli in people identified as having a narcissistic personality. People with a narcissistic personality see the world as an extension of themselves, and because of that, they regard the needs of others as less important. Narcissists, it has been noted, tend to be stubborn and envious and behave in ways that suggest they feel entitled to whatever they desire. Psychologists have also found that such traits can make a person uncomfortable to be around and that others tend to respond negatively to such behavior. They also note that narcissistic traits can be problematic for relationships, and for that reason, they have suggested that non-narcissists learn ...
- Source: drugdu
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- May 24, 2023
AbbVie and Genmab’s blood cancer therapy granted FDA accelerated approval

AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
- Source: drugdu
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- May 24, 2023
Study examines the role of hydrocortisone in the management of adult patients with septic shock

Sepsis is a global health priority affecting 55 million patients worldwide and causing 11 million deaths annually. Treatment for sepsis may include prompt recognition, source control, antibiotics, fluids, vasopressors, and adjunctive therapies. Corticosteroids have been evaluated as adjunctive therapy for septic shock for more than 50 years. Despite this substantive body of research, uncertainty persists about the effects of corticosteroids on mortality. In a study publishing May 22, 2023 in the New England Journal of Medicine: Evidence, an international team of researchers from UC San Francisco, Raymond Poincaré AP-HP Hospital, Versailles SQY University, Paris-Saclay University and Inserm, and the George Institute for Global Health in Sydney, studied the role of hydrocortisone in the management of adult patients with septic shock. They found that while the effect of hydrocortisone was modest in terms of overall survival, it was associated with a decrease in the need for vasopressor drugs and improvement in ...
- Source: drugdu
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- May 24, 2023
Bayer’s blockbuster hopeful Nubeqa, AstraZeneca’s Forxiga pick up nods from England’s NICE

Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal. After an approval last November to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), Bayer inked a deal with officials in England to make the drug available to certain patients under an early access program. Now, thanks to NICE’s endorsement in combination with androgen deprivation therapy and the chemotherapy docetaxel, the drug will be available to more patients in England and Wales, Bayer said in a release. Already, a “few hundred” patients with mHSPC have received the drug, according to Bayer. The drug scored its mHSPC approval in England last November thanks to late-stage data showing that the combination cut the risk of death by 32.5% compared with placebo. Previously, the drug had carried a NICE endorsement to treat patients ...
- Source: drugdu
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- May 24, 2023
Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease

By Tristan Manalac Pictured: Blue sign outside FDA building/JHVEPhoto/Adobe Stock The FDA has approved Krystal Biotech’s topical gene therapy beremagene geperpavec-svdt, now to be marketed as Vyjuvek, for the treatment of the rare skin disease dystrophic epidermolysis bullosa, the company announced Friday. Vyjuvek’s label covers its use in dystrophic epidermolysis bullosa (DEB) patients aged six months and above bearing mutations in the COL7A1 gene. Friday’s approval makes Vyjuvek therapy the first-ever redosable gene therapy and the first DEB therapeutic to hit the market. “Until now, there have been no approved treatment for DEB in the United States, and patients, families and physicians were limited to palliative care,” Andy Orth, chief commercial officer at Krystal Biotech, said in an investor call Friday evening, adding that there are likely around 3,000 DEB patients in the U.S., of whom some 1,100 have confirmed diagnoses, according to claims analytics. The company expects to launch ...
- Source: drugdu
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- May 24, 2023
Blueprint’s Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis

In a development that’s set to change the lives of many patients, Blueprint Medicines’ Ayvakit has finally won its long-awaited FDA approval to treat indolent systemic mastocytosis (SM). The drug won its original approval in 2021 to treat the advanced form of the disease, which affects only 5% to 10% of those with SM. Now, Ayvakit can reach the majority of SM patients, who suffer from the disease’s indolent form. The larger patient pool comprises approximately 30,000 U.S. patients, but so far only about half are diagnosed, Blueprint’s chief operating officer Christy Rossi told Fierce Pharma in an interview. Indolent SM patients often end up “living their lives in a bubble,” Rossi said. Physicians can treat symptoms, which range across organ systems from skin lesions to brain fog, but until now there was no option to treat the underlying disease. Enter Ayvakit. The drug targets a mutation called KIT D816V, ...
- Source: drugdu
- 152
- May 24, 2023

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