PharmaFocus Today – Page 281 – media

Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 166
- August 15, 2023
Supreme Court blocks Purdue Pharma’s bankruptcy settlement, threatening immunity to Sackler family

It’s been a rough summer for pharmaceutical companies trying to resolve lawsuits by declaring bankruptcy. Last month, a federal bankruptcy judge denied Johnson & Johnson’s second effort to Texas two-step its way to an $8.9 billion settlement to resolve talc claims. And now, the Supreme Court has blocked (PDF) Purdue Pharma’s bankruptcy settlement, which granted the company’s former owners—the Sackler family—immunity from civil suits related to the opioid crisis. The action is temporary as it allows the court to hear the Justice Department’s claim that a reorganization of a company under Chapter 11 can’t be used to extinguish lawsuits against “third party non-debtors”—in this case, the Sacklers—without consent of the claimants. The court will hear oral arguments in December. “We are confident in the legality of our nearly universally supported Plan of Reorganization, and optimistic that the Supreme Court will agree,” Purdue said in an email. “Even so, we are ...
- Source: drugdu
- 107
- August 15, 2023
Amylyx’s ALS drug Relyvrio gets off the ground as company eyes new brain disorder

Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio continues to wow Wall Street. Approved in the U.S. as Relyvrio and in Canada under a different brand name, the drug brought in $98.2 million in revenue during the second quarter, Amylyx said Thursday. The haul topped analysts’ consensus estimates of below $92 million, according to Mizuho Securities. Having annual revenue now tracking at $400 million after just four quarters of commercialization is no easy feat, Mizuho analyst Graig Suvannavejh, Ph.D., said in a Friday note. Besides, a strong balance sheet—Amylyx had $357 million cash as of June—means the company “faces no existential need to raise capital—an increasingly daunting challenge given a difficult equity capital markets environment,” he said. The beat was fueled by better-than-expected pricing discounts, according to Suvannavejh. New patient starts actually slowed. By the end of June, Relyvrio added 800 more patients compared with the end of March, bringing ...
- Source: drugdu
- 108
- August 15, 2023
Biotech Financings Fall, M&A Activity Expected to Pick Up

Venture capital is available, but the trending numbers do not favor startups. Deal counts have plateaued and deal sizes are down from the recent peak in 2021. These market conditions are leading startups to change their strategies in order to make the money they have last longer, according to the second quarter Venture Monitor report from Pitchbook and the National Venture Capital Association (NVCA). Breaking out biotech investments specifically, the report tallied $2.6 billion invested in 199 biotech deals globally in the second quarter, down significantly compared to the same period in 2022, when $4.8 billion was invested in 245 deals. In the U.S., Pitchbook and NVCA calculated $1.9 billion invested across 81 biotech deals in the second quarter compared to $3.3 billion invested in 93 deals in the same period last year. The report counts more than 50,000 U.S.-based venture capital-backed companies—double the number in 2016. This group now ...
- Source: drugdu
- 137
- August 15, 2023
74% of Medicare Beneficiaries Concerned About Medicare’s Long-term Sustainability

A majority of current Medicare beneficiaries, or 74%, are worried about the Medicare program’s long-term sustainability, a new survey shows. The survey was published by eHealth, an online marketplace for health insurance. It was conducted in June and included responses from 3,582 Medicare beneficiaries. The report comes after the Medicare Board of Trustees predicted that funding for Medicare Part A will not be able to cover benefits by 2031. About 20% of Medicare beneficiaries are “very worried” about the long-term sustainability of Medicare, 54% are “somewhat worried” and 25% are “not at all worried,” according to eHealth. This concern exists regardless of political opinions: About 74% of Republicans are worried and 76% of Democrats are worried. However, there’s more of a difference based on income: 25% of those with an annual income of less than $25,000 say they’re worried, versus 12% of those with an income of more than $100,000. ...
- Source: drugdu
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- August 15, 2023
ALX Oncology Axes Two CD47 Programs on Disappointing Results

By Connor Lynch Pictured: Doctor holding up hand to stop, courtesy of iStock Clinical-stage oncology company ALX Oncology is dropping trials for two of its anti-CD47 programs after disappointing efficacy findings. In its second-quarter earnings report on Thursday, the San Francisco-based company announced an end to its ASPEN-02 and ASPEN-05 programs, which were evaluating the efficacy of its CD47-inhibitor evorpacept. The protein works by binding to receptors on cancer cells that can potentially enhance the action of both chemotherapy drugs, as well as the body’s natural immune response. The two programs were assessing the effectiveness of evorpacept in concert with chemotherapy drugs to treat myelodysplastic syndrome and acute myeloid leukemia, respectively. Initial findings were promising. The combination of evorpacept and chemotherapy drugs—Bristol Myer Squibb’s azacitidine and AbbVie and Genentech’s venetoclax—proved more effective in combination than apart in early trials for myelodysplastic syndrome, as well as acute myeloid leukemia. However, later ...
- Source: drugdu
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- August 15, 2023
SCOTUS Blocks $6B Purdue Pharma Bankruptcy Settlement

By Tristan Manalac Pictured: Oxycontin bottles on a shelf/iStock, Pureradiancephoto The Supreme Court of the United States on Thursday granted the Department of Justice’s application for a stay on Purdue Pharma’s $6 billion bankruptcy settlement plan shielding the Sackler family from lawsuits related to the opioid epidemic. In the short order, SCOTUS also put any other bankruptcy proceedings against Purdue on hold. The court will schedule a hearing in December 2023 to discuss the legality of a bankruptcy settlement plan reached with state and local governments that traded the Sacklers’ immunity from civil lawsuits for a contribution of up to $6 billion. The issue at hand is whether U.S. bankruptcy laws provide protections for the Sackler family, even though they had not personally declared bankruptcy themselves. The Sacklers were previously the owners of Purdue who are alleged to have fueled the opioid-addiction crisis and required a release from liability as ...
- Source: drugdu
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- August 15, 2023
Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant

After settling with the U.S. Environmental Protection Agency (EPA) over environmental violations at one of its former plants, Genentech is on the hook for a fine of $158,208.The findings came out of a 2021 inspection of the company’s now-closed plant in South San Francisco. During the visit, EPA inspectors found several instances of the company skirting requirements related to the disposal of hazardous materials, the agency said. For one, the company stored waste without a permit and didn’t correctly monitor air emissions from the materials, according to the EPA. Plus, the overfill protection controls for a hazardous waste tank weren’t maintained at all, the agency said. Inspectors also found manifests for the waste that didn’t include all necessary federal waste codes. “When a company fails to comply with hazardous waste storage and monitoring requirements, that company puts workers and communities at risk of harmful exposures,” EPA pacific southwest regional administrator ...
- Source: drugdu
- 134
- August 14, 2023
World Health Organization classifies EG.5 as a COVID-19 ‘variant of interest’

The World Health Organization (WHO) has announced that the circulating COVID-19 strain, EG.5, has been designated as a “variant of interest”. The fast-spreading variant, which is another descendant of Omicron, has been detected in 51 countries, including the US, UK, China and Canada. In WHO’s risk evaluation, between 17 July and 23 July, EG.5 accounted for 17.4% of cases – a “notable rise” from the data reported four weeks prior, when the global prevalence of the variant was 7.6%. Despite this, the agency’s risk evaluation stated that the current “available evidence does not suggest that EG.5 has additional public health risks” and that a more comprehensive evaluation is needed. Globally, COVID-19 has caused over 6.9 million deaths, with more than 768 million cases confirmed since December 2019. In 2020, WHO declared the outbreak a pandemic and recently ended the global emergency status for COVID-19 in May this year. Despite its ...
- Source: drugdu
- 126
- August 14, 2023
GenScript and T-MAXIMUM partner for CAR-T cell therapy development

Genscript Biotech has formed a strategic collaboration agreement with T-MAXIMUM Biotech to develop CAR-T cell therapy. Leveraging GenScript’s CRISPR nucleic acid re-agents, the partnership will focus on developing T-MAXIMUM’s CAR-T cell therapy. GenScript research and development (R&D) and manufacturing vice-president Dr Li Hong stated: “Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumours. While CAR-T cell therapies have made remarkable strides in haematological tumours, addressing the unmet need for solid tumours remains crucial.” T-MAXIMUM will receive a number of CRISPR re-agents from GenScript. These will support the development of T-MAXIMUM’s universal CAR-T products from discovery to commercialisation. GenScript’s partnership with T-MAXIMUM will drive the latter’s strategic development plan, advancing products into Phase II clinical research and enabling market delivery up to 2027. T-MAXIMUM is currently focused on the development of its universal CAR-T cell therapy product, MT027, to treat recurrent high-grade gliomas. T-MAXIMUM CEO Dr Shang Xiaoyun stated: ...
- Source: drugdu
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- August 14, 2023

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