Tuesday, October 29, 2024

3 Trends I'm Watching in Sustainability

(10/28, Amalia Adler-Waxman, 3BL) ...My name is Amalia Adler-Waxman and I'm SVP Head of Sustainability at Teva. Here are the key trends I'm watching in this area...In conclusion, the sustainability landscape is evolving rapidly, driven by stringent regulations, integrated decision-making processes, and the demand for measurable impact. Companies that embrace these trends will not only comply with emerging regulations but also lead the way in creating a more sustainable healthy future... Full

Low-Cost Biosimilars Are Saving Billions, Potential Savings Are Even Greater

(10/28, Wayne Winegarden, PRI) ...Since 2019, biosimilars have obtained a majority share of most markets where they compete. The combination of lower prices (both biosimilar and originator) and rising market share could have generated up to $35 billion in savings in 2024 dollars compared to an all-originator baseline based on PRI's latest analysis. These savings demonstrate that, just like with small molecule medicines, biosimilars strike a beneficial balance between incentivizing innovation and promoting affordability... Full

Samsung Bioepis Reports Q3 Sales Growth, Despite ‘Absence Of Milestones'

(10/28, Urte Fultinaviciute, Generics Bulletin) ...The Korean firm reported sales of KRW330bn ($239.22m), which was a 26% increase compared to the same quarter last year's sales of KRW262bn...Indeed, last quarter Samsung Bioepis had a "remarkable performance", achieving triple-digit revenue growth thanks to the expansion of new product sales and the inflow of milestone revenues. Still, the biosimilars division "achieved several notable advancements" in the third quarter, wrote Samsung Biologics' president and CEO John Rim in an investor relations newsletter... Global Sub. Full

Sun Pharma Shines in US, Home Glow to Help Company Beat Industry Show

(10/29, Kiran Somvanshi, The Economic Times) ...Company's US business - constituting a third of the total revenues - has grown 22% driven by the promising growth being charted by its specialty business. The underlying performance of Sun's specialty portfolio remains strong, and the company is aggressive in growing this business... Sub. Req’d

India's Cipla Beats Q2 Profit View On Strong US, India Demand

(10/29, Kashish Tandon, Reuters) ...Cipla, India's third-largest generic drugmaker by sales, reported a 15.2% rise in second-quarter profit that beat estimates, driven by higher sales of its respiratory and cancer drugs in its key India and North American markets...Cipla's domestic revenue has been under pressure due to a shift in the distribution channel for its trade generics business. The company said it expects growth in this business to recover in the near term... Full

Novartis Cancer, Heart Drugs Disappoint as Company Lifts Targets

(10/29, Ashleigh Furlong and Naomi Kresge, Bloomberg) ...Sales of heart failure medication Entresto fell short of expectations, while closely watched cancer drug Pluvicto only beat estimates because of a one-time gain. Novartis shares fell as much as 4.3% in early Swiss trading, paring the gain this year to 14%...On obesity, Narasimhan reiterated that Novartis is focused on next-generation technologies that could improve the profile of current weight-loss drugs in terms of side effects, the frequency of dosing or the preservation of muscle. "In the meantime, we feel like we have a full pipeline of medicines in cancer, in immunology, in neuroscience and cardiovascular disease such that we're not really reliant on the obesity wave," he said... Full

Awaiting Expanded Approvals, Lilly and J&J Release Late-Stage Data for Crohn's Treatments

(10/28, Katherine Lewin, Endpoints News) ...In the Phase 3 GRAVITI study, J&J's subcutaneous Tremfya bested placebo by demonstrating "significant" clinical remission and endoscopic response at 48 weeks in adults with moderate-to-severe active Crohn's disease, the company said...Lilly's latest data for Omvoh (mirikizumab) also bested placebo in two late-stage studies, showing long-term remission across both ulcerative colitis and Crohn's disease. Omvoh already scored an FDA approval last year in ulcerative colitis, and applications for a label expansion into Crohn's have already been submitted... Full

AbbVie Banks On Alzheimer's Therapy with $1.4 Billion Buy of Aliada

(10/28, Sabrina Valle; Sriparna Roy and Puyaan Singh, Reuters) ...U.S. drugmaker AbbVie said on Monday it will buy Aliada Therapeutics for $1.4 billion in cash, betting on an experimental Alzheimer's treatment still in the early stage of development...AbbVie is expanding its neuroscience portfolio as it faces a 33% drop in sales of its blockbuster arthritis drug Humira. Once the world's top-selling medicine, Humira is now facing competition from several less expensive biosimilar versions of the drug... Full

WuXi AppTec is Still Signing On New Clients Despite Biosecure Threat

(10/28, Anna Brown, Endpoints News) ...On Monday, the services company said it had signed on a total of 800 new customers in the first three quarters of the year, which is 300 more than it signed in the first half of 2024. It has "maintained the existing base of 6,000+ active customers," according to its third-quarter earnings presentation... Full

Baxter Ramps Up Production, FDA Extends IV Drug Expiration Dates

(10/28, Jessica Karins, InsideHealthPolicy) ...Baxter International will likely resume standard production on its highest-throughput manufacturing line for IV solutions, the company said in a statement Monday (Oct. 28), after its facility in North Carolina was flooded during Hurricane Helene, leading to shortages of several IV drug products. FDA is also allowing shelf-life extensions for several of Baxter's IV drug products, and the company says it may soon be able to provide drugs to more peritoneal dialysis patients after limiting new patients to children only... Sub. Req’d

Granules Consumer Health to Expand Manufacturing Operations in Prince William County

(10/28, Governor Glenn Youngkin) ...Governor Glenn Youngkin today announced that Granules Consumer Health, a subsidiary of Granules India and a manufacturer of over-the-counter and prescription pharmaceuticals, will invest $1.5 million to expand its operations in Prince William County. The company will install new manufacturing lines at its existing facility, creating 99 new jobs... Full

Biosimilars Expand Access and Reduce Costs in Oncology, Immunology

(10/28, Cameron Santoro, AJMC) ...Biosimilars are reducing healthcare costs and improving patient access, with over 60 FDA-approved products across multiple therapeutic areas. Denosumab biosimilars in oncology could save up to $117.5 million over five years, depending on uptake and pricing. Adalimumab biosimilars offer significant cost savings compared to Humira, enhancing treatment access and equity on a budget-neutral basis... Full

The Future of Biosimilars: Learning from Prior Mistakes

(10/28, Mark Campbell, PharmD, Pharmacy Times) ...In the next few years, a wave of biosimilars could revolutionize how chronic diseases and serious conditions are treated. But without the right systems in place, future biosimilars will suffer a similar fate as those already launched and the cost of repeating the same mistakes and doing nothing is just too high... Full

Specialty Pharmacist Paving the Way for Biosimilar Adoption

(10/28, Killian Meara, Drug Topics) ...In a conversation with Drug Topics, [Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic] discussed some of the rewards and challenges she faces in her setting, a specific program she implemented that exemplifies the value of pharmacists in patient care, what the biggest opportunities are for pharmacists to expand their role in patient care in today's health care landscape, and how biosimilars will impact the pharmacy profession in the coming years... Full

What is the Pharmacy of the Future?

(10/28, Natasha Spencer-Jolliffe, Pharmaceutical Technology) ...In the post-Covid-19 era, drug shortages are putting extra strain on pharmacists and patients. Pharmacists are trying to manage stock levels and process prescriptions quickly while protecting patients' health and safety. With pharmacies getting involved in clinical trials and prescription services, pharmacists are under pressure to juggle the two and try to implement these dual demands into their workflows... Full

HealthJoy, Cost Plus Drugs Partner To Reduce Drug Costs for Employers

(10/28, Marissa Plescia, MedCity News) ...HealthJoy is able to point people to Cost Plus Drugs through its Rx Savings tool, which is free to all members and their families. In addition, HealthJoy's concierge team is able to find cost savings for members and can assist them in accessing Cost Plus Drugs for lower-cost generics... Full

VCs Move to Launch U.S.-Based Companies to Develop Drugs Developed in China

(10/29, Brian Yang, STAT Plus) ...U.S. companies have long signed licensing deals with Chinese drugmakers. But increasingly American venture capitalists are building U.S.-based companies from scratch to test and ultimately seek to commercialize innovative drugs developed in China... Sub. Req’d

Generics Anticipate Difficulties As Likely BIOSECURE Passage Looms

(10/28, Jessica Karins, InsideHealthPolicy) ...The BIOSECURE Act is expected to be included in a legislative package before the end of the year, and legal experts on the generic drug industry are warning that the bill, which aims to cut off federal contracting with biotech companies tied to adversarial countries, will be costly, technically complex and likely lead to more drug shortages... Sub. Req’d

Biden Administration Launches Pilot to Mitigate Pediatric Cancer Drug Shortages

(10/28, Heather Landi, Fierce Healthcare) ...The White House announced a new private sector pilot program to maintain uninterrupted access to seven pre-selected critical pediatric cancer medications...The pilot, coordinated by the End Drug Shortages Alliance, involves children's hospitals and pharmaceutical distributors. The pilot will launch before the end of the year and run into 2025. At the end of the pilot, the End Drug Shortages Alliance will publish a report on the pilot, including key learnings and opportunities to scale... Full

Industry Voices—Cancer Is Always a Catastrophe. But One Provision of The Inflation Reduction Act Is Trying to Change That

(10/28, Brad Diephuis, Fierce Healthcare) ...We need mechanisms that deliver optimal treatments to older Americans facing catastrophic health issues, regardless of their income bracket. Being thoughtful about how prescription drug policy impacts cancer patients will help us make meaningful strides toward overall improvement of our healthcare system... Full

I'm the Director of the Center for Medicare. Here's How We Executed the First Round of Drug Price Negotiation

(10/29, Meena Seshamani, STAT) ...Prioritizing collaborative engagement with drug manufacturers, patients, health plans, clinicians and others quickly crystallized our clear, shared goal: ensuring that people with Medicare have access to innovative cures and therapies that they need at a price they can afford... Full

Employers Eye PBM Changes, Fearing Legal Threat

(10/29, Tina Reed, Axios) ...Employers worried about lawsuits from workers charging they're not spending their health care dollars wisely are increasingly casting a more critical eye on the middlemen that help manage their drug costs...More than half of 188 companies polled in September and October are considering a change to their PBM in one to three years, per a new survey from the National Alliance of Healthcare Purchasers... Full

How Policy Reforms in PBM Systems Could Change the Adalimumab Market

(10/28, Skylar Jeremias, The Center For Biosimilars) ...Panelists at the GRx+Biosims conference discussed the need for increased transparency and policy reforms within pharmacy benefit management (PBM) systems to support the accessibility, affordability, and fair competition of adalimumab biosimilars. The conference was held from October 21 to October 23, 2024, in Rockville, Maryland... Full

Insurers Continue Shifting More Costs On To Patients

(10/28, Nick McGee, PhRMA) ...As patients pay more for their medicines out-of-pocket, PBMs and insurers benefit from rebates and discounts that lower their prices for those same medicines, according to a recent report from the Bureau of Economic Analysis...As the report found, concerns about the cost of prescription drugs, "align more closely with the persistent increase in out-of-pocket prices than the recently stagnating growth of negotiated prices."... Full

Bipartisan Letter Questions FDA's 'Narrow' Interpretation for Priority Review Vouchers

(10/28, Zachary Brennan, Endpoints News) ...Sen. Tim Scott (R-SC) and Rep. Danny Davis (D-IL) are questioning the FDA's "narrow" interpretation of "active ingredient" when it comes to awarding the potentially lucrative priority review vouchers... Full

Woodcock Throws Weight Behind Push For New Legislative ‘Substantial Evidence' Standard For Rare Disease Drugs

(10/28, Sarah Karlin-Smith, Pink Sheet) ...Woodcock and the Haystack Project want to modify a foundational concept of modern FDA drug efficacy assessments, which may be seen as an attempt to more formally codify and define regulatory flexibility... Global Sub. Full

Cross-Country HTA Collaboration To Focus On Health Economics & RWE

(10/28, Francesca Bruce, Pink Sheet) ...European cross-country HTA collaborations have much to learn from each other to keep drug prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent... Global Sub. Full

New Initiative to Strengthen Danish Pharma Production

(10/28, The Pharma Letter) ..."It is a really positive move from the government, which has the potential to make a big difference in terms of strengthening expansions and attracting life science production to Denmark. These are concrete initiatives that will make it easier for companies to navigate complex processes involving many authorities. It will increase transparency, reduce uncertainties and thus make it more attractive to invest in Denmark," says Ida Sofie Jensen, chief executive of Lif - the Pharmaceutical Industry Association of Denmark, about the government's new growth plans... Sub. Req’d

Italy Sets Up Project To ‘Break Industry Monopoly' On Drug Information

(10/28, Ian Schofield, Pink Sheet) ...The Italian medicines regulator, AIFA, and the regional health authorities have set up a new publicly-funded network that intends to publish "independent" information to help foster the appropriate use of medicines and "break the pharmaceutical industry's monopoly on medicine information."... Global Sub. Full

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