PharmaFocus Today – Page 347 – media

FDA warns Sure-BioChem over quality and data issues

By Tyler Patchen News Reporter https://endpts.com/fda-warns-sure-biochem-over-quality-and-data-issues/ A warning letter has been given to a company that tests finished drug products over several quality issues. The FDA issued the warning letter to Sure-BioChem Laboratories, a Camden, NJ-based contract test laboratory that does microbial testing on products including finished drugs. Sure-BioChem was inspected late last year, but the regulator has advised the company that it still needs to make some corrections. The letter said that inspectors found that the company had failed to establish and follow procedures for some of its tests and it had not validated its use of “alternative microbial methods” used to test drug products to ensure that its methods were “Specifically, you failed to adequately establish that your microbiological testing methods can reliably detect objectionable microorganisms,” the letter said. Sure-BioChem’s methods also failed to detect Burkholderia cepacia complex (Bcc) bacteria and reported “not detected” to a client. The ...
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- May 25, 2023
Roche Terminates Second Phase II Schizophrenia Trial

By Kate Goodwin https://www.biospace.com/ Pictured: Blue Roche logo on white building/Smith Collection/Gado/Getty Images Roche has terminated a second Phase II trial of its investigational schizophrenia drug ralmitaront, leaving an uncertain future for the company’s program targeting the psychiatric disorder. The first trial, which was canceled last year, was studying the effects of ralmitaront as a monotherapy in patients with an acute exacerbation of positive symptoms of schizophrenia or schizoaffective disorder. The second trial, which was recently terminated, was investigating the impact of the treatment on negative symptoms associated with the two conditions. “In a preliminary analysis, the primary endpoint was negative, and ongoing portions of the study have therefore been discontinued,” according to an update on the second Phase II trial posted to the ClinicalTrials.gov website. Roche’s latest first quarter 2023 pipeline presentation included the asset, pushing its New Molecular Entity submission back into the “2026 and beyond” category. No ...
- Source: drugdu
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- May 25, 2023
analysts

Dive Brief: Growth in parts of the orthopedic market will start to normalize late this year as surgeons work though a backlog of cases that had been postponed by the COVID-19 pandemic, analysts at Needham wrote. The analysts expect hip growth to normalize late this year and the knee and spine markets to slow down by the end of 2024. In the trauma and extremities market, the analysts see potential for “above-normal growth for some time.” A slowdown in capital spending by hospitals, currency fluctuations and supply chain issues are among factors the analysts said could hurt revenue for a number of the orthopedic companies. Dive Insight: Orthopedic companies have made a fast start to 2023, with Zimmer Biomet’s CEO saying “pretty much everything went better than expected” in the first quarter and an analyst admitting to being “kind of blown away by how good the growth rates were in ...
- Source: drugdu
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- May 25, 2023
Indivior’s Opvee crosses FDA finish line, adding new overdose rescue option amid raging opioid epidemic

Just two months after Emergent BioSolutions made history by winning the FDA’s blessing to sell its opioid reversal medicine over the counter, a new treatment option has arrived in Indivior’s Opvee. The nod, which covers Opvee’s use in people 12 years of age and older, marks the first approval for the medicine’s active ingredient in nasal spray form. The molecule, nalmefene hydrochloride, was first approved in the 1990s in an injectable format but was later pulled from the market in 2008. This time around, the FDA endorsed the drug based on new evidence that it can help combat rising overdose rates in the U.S. Indivior, which closed its purchase of Opiant in March and picked up the medicine in that buyout, plans to launch Opvee in the fourth quarter of 2023. The FDA’s approval comes as overdoses attributable to synthetic opioids such as fentanyl are on the rise, with more ...
- Source: drugdu
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- May 25, 2023
Study reveals unique molecular machinery of woman who can’t feel pain

The biology underpinning a rare genetic mutation that allows its carrier to live virtually pain-free, heal more rapidly and experience reduced anxiety and fear, has been uncovered by new research from UCL. The study, published in Brain, follows up the team’s discovery in 2019 of the FAAH-OUT gene and the rare mutations that cause Jo Cameron to feel virtually no pain and never feel anxious or afraid. The new research describes how the mutation in FAAH-OUT “turns down” FAAH gene expression, as well as the knock-on effects on other molecular pathways linked to wound healing and mood. It is hoped the findings will lead to new drug targets and open up new avenues of research in these areas. Jo, who lives in Scotland, was first referred to pain geneticists at UCL in 2013, after her doctor noticed that she experienced no pain after major surgeries on her hip and hand. ...
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- May 25, 2023
The power of genetics — how research into gene sequencing could revolutionize biopharma

Unlocking the potential of human genetics is key to many advances in the biopharma industry. From immunotherapies that treat cancer to potential cures for rare diseases to mapping the genome for incredible medical discoveries, researchers have still only scratched the surface of what is possible in gene science. Just last week, the FDA approved the first-ever gene therapy that can be applied directly to the skin to treat patients known as “butterfly children” because of how fragile their skin can be. These kinds of forward-thinking medicines have come about due to the ever more advanced understanding of how genetics cause certain conditions. And early research in the genetic space — even that which might not appear directly related to medicine — has given scientists the tools to make better treatments down the road. Some of those treatments are on their way to helping patients soon. One cell therapy in late-stage ...
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- May 25, 2023
Crick Institute announces new molecular glue discovery to treat different diseases

A combined investment of £11.2m that includes a prosperity partnership grant from the Engineering and Physical Sciences Research Council (EPSRC) and funds from AstraZeneca (AZ) has enabled researchers at the Francis Crick Institute, Imperial College London and AZ to discover new ‘molecular glues’ to treat multiple diseases. Widely used as protein degraders, molecular glues bring together proteins that would not usually interrelate. The glues manage the modification and degradation of disease-causing target proteins by redirecting them to the cell’s natural waste disposal system. By facilitating the interaction between target protein and a cellular enzyme, the target protein is deactivated or broken down by additional proteins that are recruited by the enzyme. Group leader at the Crick Institute, Ed Tate, said: “Challenges arise when we can’t find a small molecule with the ability to interact with certain proteins. “If we can redirect these harmful proteins towards the cell’s own waste disposal ...
- Source: drugdu
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- May 25, 2023
A larger dose of vitamin D may decrease psychiatric symptoms at school age

It is estimated that every eighth child suffers from a mental health disorder. Several predictors of children’s mental problems have been identified, but much remains uncharted. Previous research suggests that low vitamin D levels in early childhood may be one factor increasing the risk of mental health problems in later life. A recent Finnish study, now published in JAMA Network Open, presents new information on the association between vitamin D intake and mental health. A new study by a team of Finnish researchers has investigated whether a daily vitamin D3 supplement higher than the recommended dose in early childhood reduces the risk of psychiatric symptoms at school age. The study is part of the Vitamin D Intervention in Infants (VIDI) clinical trial, which investigates how early vitamin D3 intervention affects children’s growth and development. In the research, children were randomized as two groups, one receiving the daily standard dose of ...
- Source: drugdu
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- May 25, 2023
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
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- May 24, 2023

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