Wednesday, January 3, 2024

Corcept Loses Patent Fight With Teva Over Cushing's Syndrome Drug

(1/2, Katherine Lewin, Endpoints News) ...Corcept Therapeutics lost its patent infringement lawsuit against Teva Pharmaceuticals over its Cushing's syndrome drug Korlym after a New Jersey judge ruled in Teva's favor...A Teva representative said in an email that the company is "pleased" with the outcome of the lawsuit... Full

Piper Sandler Upgrades Teva Pharma (TEVA) to Neutral

(1/3, StreetInsider.com) ...The analyst comments "We are upgrading Teva to Neutral from Underweight and raising our PT to $12 from $8. As we move into 2024, it is becoming clear to us that senior leadership's greater lean into brand assets likely translates into less in the way of downside risk, particularly as Teva gradually chips away at its overall debt burden.”... Sub. Req'd

Teva Upgraded to Neutral from Underweight at Piper Sandler

(1/2, The Fly) ...Piper Sandler analyst David Amsellem upgraded Teva Pharmaceutical to Neutral from Underweight with a price target of $12, up from $8... Full

Piper Upgrades Teva On Neutral On Less Downside Risk in 2024

(1/3, The Fly) ...Senior leadership's "greater lean" into brand assets likely translates into less in the way of downside risk in 2024, particularly as Teva gradually chips away at its overall debt burden, the analyst tells investors in a research note. The firm finds it difficult to envision further multiple compression in the shares. However, Piper still sees a lack of visibility into the extent to which Teva's new brand assets can drive actual EBITDA growth... Full

Biotech, Pharma Growth Stocks Set for Better 2024: Analysts

(1/2, Sean Mason, Proactive Investors) ...BofA analysts are encouraged by sector fundamentals, including research and development output and external demand for biotech innovation as measured by merger and acquisition trends...Their top stock opportunities in the space for this year are Vaxcyte Inc, Teva Pharmaceutical Industries, Intra-Cellular Therapies Inc, and Tarsus Pharmaceuticals Inc. Analysts like Vaxcyte because the company significantly de-risked its Phase 3-ready 24-valent pneumococcal vaccine [VAX-24] with the broadest spectrum of disease coverage, while they see Teva's brand/generic hybrid poised for a breakout year driven by commercial outperformance of key CNS brands and two high impact clinical catalysts... Full

Mark Cuban's Cost Plus Drugs Sparks Others To Change How Rx Meds Are Priced

(1/2, Joshua Cohen, Forbes) ...Two years in, Mark Cuban's company keeps shaking up the generic pharmaceutical space. It added another 1,000 medicines in December to the list of now 2,200 drugs it sells directly to patients. The firm now offers prescription drugs—mostly generics—to over 2 million members...And as for future plans, Cuban owns a 22,600-square-foot office and warehouse which will be used to create a fill and finish factory for generic drugs. The facility will serve as a pilot for prospective commercial manufacturing sites, with an emphasis on producing prescription drugs that are currently on the Food and Drug Administration's list of products facing shortages... Full

Why An Inhaler Switch Has Pediatricians Worried

(1/3, Tina Reed, Axios) ...Pediatricians, in particular, are frustrated that their patients might not have an age-appropriate alternative if the generic isn't covered. Flovent had been preferred by many pediatricians because the inhaler made it possible to use the drug in the youngest children, Erin Syverson, an attending physician at Boston Children's Hospital, told Axios...Some insurers told Axios they are covering the generic version of Flovent in cases it is medically necessary. That includes UnitedHealthcare, the nation's largest health insurer... Full

Coherus Eyeing US Pegfilgrastim Bulk With On-Body Injector Approval

(1/3, Dean Rudge, Generics Bulletin) ...Coherus BioSciences is set to become the first company to offer biosimilars to Amgen's complete range of Neulasta (pegfilgrastim) products, after obtaining approval from the US Food and Drug Administration for the company's version of the Neulasta Onpro on-body injector device using Coherus' Udenyca (pegfilgrastim-cbqv) biosimilar... Global Sub. Full

Alvotech's AVT06 Shows Promise in Clinical Study, Poised to Offer Effective Alternative to Eylea

(1/3, Muhammad Jawad, BNN) ...Alvotech, a global biotech company, has made a promising stride in the medical field with the announcement of positive results from a clinical study for AVT06, a biosimilar to Eylea (aflibercept)...The introduction of AVT06 could pose a considerable shift in the market dynamics, offering a potentially cheaper alternative. Alvotech's product pipeline extends beyond eye disorders, including treatments for autoimmune disorders, osteoporosis, respiratory diseases, and cancer... Full

AstraZeneca, Sanofi Win Nod in China for RSV Antibody Beyfortus

(1/2, Kevin Dunleavy, Fierce Pharma) ...AstraZeneca and Sanofi have scored first in China with an approval for their respiratory syncytial virus immunization Beyfortus for infants, with the companies expecting the shot to be available there for the 2024-25 season...A Sanofi spokesperson said that the company is working with AZ to "actively plan for supply" during the 2024-25 RSV season... Full

Alembic Pharma Receives Eight US FDA Approvals in Q3FY24

(1/3, Pharmabiz.com) ...that includes selexipag tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg, dapsone gel, 7.5%, fluorouracil Injection USP 5g/100mL (50 mg/mL), pharmacy bulk package (Vial), carmustine for injection USP 100 mg/vial (Single-dose Vial) and acyclovir cream, 5%. The company has also received three tentative approvals that includes rivaroxaban tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, dapsone gel, 7.5%, bromfenac ophthalmic solution, 0.07%., and osimertinib tablets, 40 mg and 80 mg... Full

Dr. Reddy's Acquires MenoLabs to Address Symptoms of Perimenopause and Menopause Among Women

(1/3, Financial Express) ...Dr. Reddy's Laboratories Ltd. on Wednesday announced that it has acquired the MenoLabs business, a women's health and dietary supplement branded portfolio from Amyris, Inc. in Amyris' Chapter 11 sales process. Dr. Reddy's acquired the entire MenoLabs supplements portfolio which includes seven branded products designed to provide health support and address symptoms of perimenopause and menopause... Full

Natco Pharma Limited Completes Transition of DASH Pharmaceuticals into Natco Pharma USA, Furthering Strategic Presence in the United States

(1/2, Natco Pharma) ...Natco Pharma Limited, a research and development-focused pharmaceutical company based in India, today announced that DASH Pharmaceuticals, a company that markets, sells, and distributes generic pharmaceutical products, has officially transitioned to Natco Pharma USA, the U.S. subsidiary of Natco Pharma. As of January 2, all products marketed by the company will transition to the Natco Pharma USA label, with no changes to the current NDC Numbers... Full

Glenmark Launches Biosimilar of Anti-Diabetic Drug, Vows to Cut Down Therapy Cost by 70%

(1/3, Neethi Rojan, Money Control) ...Glenmark Pharmaceuticals said it has launched a biosimilar of the popular anti-diabetic drug, Liraglutide, for the first time in India that will lower the cost of therapy by 70 percent...The drug is being marketed under the brand name Lirafit following approval from the Drug Controller General of India. Priced at Rs 100 for a standard daily dose of 1.2mg, the drug will be available only under prescription... Full

Big Pharma Shouts, Generics And Biosimilars Whisper: M&A In 2023

(1/3, Dean Rudge, Generics Bulletin) ..."A lot of companies are hurting because of the higher interest rates," one major CEO observed recently, summing up a year which saw little headline-grabbing news on the M&A front for generic and biosimilar sponsors. At the midway point of 2023, dealmaking for big pharma had roared back to life following relative austerity in the previous two years, as credit became harder to come by, interest rates spiked, and lenders tightened up in a challenging and volatile market... Global Sub. Full

Biden Memo Lets HHS Use DPA To Fight Drug Shortages

(1/2, Jessica Karins, InsideHealthPolicy) ...A new presidential determination gives HHS more authority to boost manufacturing of essential medical products through the Defense Production Act, which the department plans to immediately use to hike domestic production of starting materials for sterile injectable drugs. President Joe Biden issued the determination in a memo to the HHS secretary on Dec. 27. The White House had announced in November that it would make the determination as one of several actions to increase the resiliency of the domestic drug supply chain... Sub. Req'd

Federal, State Drug Pricing Plans Prompting Deeper Challenges

(1/3, Christopher Schott, Bloomberg Law) ...The pharmaceutical industry faced pressure and uncertainty in 2023 and that will likely continue in 2024, partially because of the implementation and evolution of the Inflation Reduction Act. Meanwhile, states are expected to continue their increasingly aggressive attempts to regulate drug pricing...Multiple pharmaceutical manufacturers challenged the health-care law in court in 2023, largely on constitutional grounds. These suits will continue through 2024, and it's likely the constitutional claims will be supplemented with as-applied challenges as the law begins to have real-world effects... Full

PBMs, Telehealth, Transparency Lead Congress' 2024 To-Do List

(1/3, Michael McAuliff, Modern Healthcare) ...The House, in one of its last major actions of 2023, passed the Lower Costs More Transparency Act of 2023, which would require hospitals, laboratories, PBMs and others to release information on prices and crack down on how PBMs negotiate prescription drug prices for employers and health insurance companies. The Senate has not moved a similar bill to the floor, but the Finance Committee and the Health, Education, Labor and Pensions Committee have passed bipartisan legislation that includes many of the same items... Sub. Req'd

How to Put a Lid on Your Drug Costs in 2024

(1/3, Peter Loftus, The Wall Street Journal) ...Health-insurance deductibles reset on Jan. 1. That means, if your deductible applies to your prescription-drug costs, you could be on the hook for thousands of dollars while you're spending down the deductible and more favorable insurance coverage kicks in...Beginning in January 2024, there will be an effective annual cap on out-of-pocket costs of about $3,300 for brand-name prescription drugs in Medicare Part D plans. The out-of-pocket cap falls to $2,000 in 2025, a big help for people taking expensive drugs. Previously, there was no cap on out-of-pocket spending, and some patients were on the hook for several thousands of dollars a year... Sub. Req'd

CSRXP: Big Pharma Rings in 2024 with Egregious Price Hikes On Hundreds of Brand Name Prescription Drugs

(1/2, The Campaign For Sustainable Rx Pricing) ..."Big Pharma ringing in the new year with yet another round of egregious price hikes on hundreds of brand name prescription drugs demonstrates the pharmaceutical industry will maintain its business-as-usual approach to price-gouging Americans in 2024," said CSRxP executive director Lauren Aronson. "As Congress reconvenes this month, lawmakers must take note of Big Pharma's continued commitment to putting profits over people through egregious pricing and anti-competitive practices and focus on holding brand name drug companies accountable to lower drug prices."... Full

Yale Law School's Free Speech Group says Boehringer's IRA Argument is 'Fundamentally Flawed'

(1/2, Nicole DeFeudis, Endpoints News) ...Yale Law School's Floyd Abrams Institute for Freedom of Expression described Boehringer Ingelheim's First Amendment arguments in its Inflation Reduction Act lawsuit as "extraordinarily troubling."...The contracts regulate conduct, not speech, the institute argued in an amicus brief filed on Dec. 28. It also noted that participation in negotiations is voluntary and "neither compels nor limits plaintiffs' protected speech to any extent."... Full

NY Governor Touts Complete Ban Of Insulin Copays, But Health Plan Org Skeptical

(1/2, Gabrielle Wanneh, InsideHealthPolicy) ...New York Governor Kathy Hochul (D) on Tuesday (Jan. 2) announced plans to propose legislation this year that would ban copays for insulin across the state. But the New York Health Plan Association says the move could end up shifting costs into other facets of the pharmaceutical supply chain because it fails to address the broader issue of exorbitant prices and price hikes by drug companies... Sub. Req'd

19 Congressional Democrats To USTR: Oppose COVID TRIPS Waiver Expansion

(1/2, Gabrielle Wanneh, InsideHealthPolicy) ...Nineteen House Democrats are urging the U.S. trade representative to oppose any efforts by the World Trade Organization to expand the temporary intellectual property waiver for COVID-19 vaccines to also include diagnostics and therapeutics, saying an expansion of the waiver could stifle domestic biomedical innovation... Sub. Req'd

US FDA Approvals Bounce Back in 2023, Sparking Hopes of a Biotech Recovery

(1/2, Manas Mishra and Pratik Jain, Reuters) ...The U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an improvement analysts and investors said could lead to increased investment in biotech firms...Industry analysts also said lingering investor concern about high interest rates and government scrutiny of drugmakers could hamper a full funding recovery. "While we don't expect capital markets to return to peak 2020-21, we do think that conditions will improve and that the window will open up," Jefferies analyst Michael Yee said... Full

FDA Finalizes Guidance to Limit Use of Benzene in Drug Products

(1/2, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration recently finalized a guidance to expedite the reformulation of drug products that use inactive ingredients manufactured with benzene, which the agency called a "known carcinogen."...In an announcement, FDA said it "encourages manufacturers to implement reformulation as soon as possible. Given the high priority for public health, FDA is issuing this guidance to become immediately effective without prior comment."... Full

Triumphs And Crises: European Industry Chief Reflects On The Past Ten Years

(1/2, David Wallace, Generics Bulletin) ...In the second part of a three-part interview with Generics Bulletin, Medicines for Europe director general Adrian van den Hoven discusses the rise in prominence of biosimilars in Europe, reflects on off-patent industry efforts to deal with crises such as the COVID-19 pandemic and the war in Ukraine, and highlights achievements such as the SPC manufacturing waiver... Global Sub. Full

How The EU's Landmark AI Act Could Impact The Pharma Industry

(1/2, Eliza Slawther, Pink Sheet) ...Alison Dennis, partner and co-head of the international life sciences team at law firm Taylor Wessing, told the Pink Sheet during an interview how the AI Act could impact the pharmaceutical industry, both directly and indirectly, and explained where she has seen AI used the most during the drug lifecycle. According to Dennis, any medicines that interact with or rely on medical devices or diagnostics, such as precision therapies or other individualized treatments, have a high potential for AI to be utilized and therefore to be affected by the AI Act... Sub. Req'd

UK's New International Recognition Procedure A ‘Win-Win' For Stakeholders

(1/2, Ian Schofield, Pink Sheet) ...From January 1, pharmaceutical companies seeking a marketing authorization from the UK regulator, the MHRA, can use the new International Recognition Procedure, under which the MHRA will be able to take account of approval decisions taken by seven other world regulators. The IRP, which is intended to accelerate assessments at the MHRA, offers two routes to approval, Recognition A and Recognition B... Sub. Req'd

New Canadian Drug Agency To Focus On Drug Access & Affordability

(1/2, Neena Brizmohun, Pink Sheet) ...The government of Canada is investing CAD$89.5m ($67.4m) over five years to establish a new agency to improve access to prescription drugs and make them more affordable...The new agency is needed because "Canadians are left vulnerable due to high drug costs, inaccessible health data, and the lack of consistent standards for prescribing practices," according to Health Canada... Sub. Req'd

From Pharmacy of World, India Moves to Innovation in Pharma

(1/3, Swati Bharadwaj and Sindhu Hariharan, The Times Of India) ...No longer is India just the 'pharmacy of the world', manufacturing and exporting bulk drugs and affordable generic medicines, it is also now rapidly emerging as a hub of pharma innovation and digitisation, as global pharma giants home in on India for their global capability centres. Be it mature GCCs of Danish giant Novo Nordisk and Swiss behemoth Novartis, which came up over 15 years ago, or younger ones like Roche, big pharma is counting on Indian talent to drive future growth. The centres here support global functions such as clinical trials, pharmacovigilance and drug safety, and regulatory drug filings. They chip in with drug discovery and help the parent companies leverage emerging technologies such as Gen AI, AR/VR, and IoT... Full

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