Monday, March 4, 2024

UroGen Falls as Teva Seeks FDA Nod for Jelmyto Generic

(3/1, Dulan Lokuwithana, Seeking Alpha) ...Shares of UroGen Pharma fell premarket Friday after Teva Pharmaceutical submitted a marketing application to secure FDA approval for a generic version of the U.S. biotech's bladder cancer therapy, Jelmyto...The Israeli drugmaker has notified URGN that the company's generic version will not violate IP rights related to Jelmyto as two of its patents listed in the FDA Orange Book "are invalid, unenforceable, or will not be infringed." "We are only at the beginning of tapping into the market opportunity of what we've pioneered, and clearly, others are now seeing the potential," URGN CEO Liz Barrett remarked... Full

Many Costly Generic Drugs Are Unavailable at Amazon, Cuban, and Other Alternative Pharmacies

(3/1, Ed Silverman, STAT Plus) ...Of 100 expensive generics used to treat such diseases as cancer, HIV, or multiple sclerosis, 20% were not available at one or more of these pharmacies. Of 88 expensive generics that were available in comparable quantities and strengths in all of the pharmacies, 47% were least expensive at Amazon, 26% were cheapest at the Cuban company, 14% at Health Warehouse, and only 13% were cheapest at Costco. However, nearly all - 98% - of 50 commonly used generics were widely available, although pricing also varied among what the researchers called direct-to-consumer pharmacies... Sub. Req'd

‘It's a Nightmare': One of the Most Common Children's Asthma Meds is No Longer Available, Leaving Families Scrambling

(3/3, Jason Laughlin, The Boston Globe) ...In a letter Friday to GSK chief executive Emma Walmsley, Warren accused the company of "price gouging" by killing its production of the widely used medication in order to avoid new government regulations that would have cost the pharmaceutical giant money. Instead, GSK has contracted with the drugmaker Prasco Laboratories to manufacture an authorized generic version. "GSK has avoided accountability for aggressive price hikes on their life-saving drugs, and now, just ahead of allergy season, they've effectively ripped a go-to inhaler out of the hands of kids," Warren said in a statement to the Globe Friday... Full

Sandoz Completes Coherus Biosimilar Acquisition

(3/4, David Wallace, Generics Bulletin) ...Sandoz has announced the early completion of its deal to acquire the Cimerli (ranibizumab-eqrn) US biosimilar franchise from Coherus BioSciences. The deal for the interchangeable rival to Lucentis – first announced in late January – will see Coherus' dedicated retina sales and field reimbursement team integrated into Sandoz, "ensuring seamless experience for providers and patients," according to the company... Global Sub. Full

Biogen Needs Leqembi to Be Successful Following Discontinuation of Aduhelm, Says GlobalData

(3/4, Financial Express) ...Pippa Salter, Senior Neurology Analyst at GlobalData, comments: "By discontinuing Aduhelm, which has failed to have a significant impact in the market with sales revenue falling flat, Biogen can now fully focus on the continued commercialization of Eisai-partnered Leqembi (lecanemab), an anti- Aß mAb that received full FDA approval for the treatment of mild AD and mild cognitive impairment in July 2023. "The success of Leqembi will be crucial for Biogen moving forward, particularly after the lack of return from the significant investment the company put into Aduhelm. Aduhelm-specific sales were excluded from the company earnings being reported by Biogen in 2023, rather the drug was included in ‘Other products' revenue... Full

Aurobindo Pharma Soars 4% On USFDA Nod to Manufacture Fingolimod Capsules

(3/2, Money Control) ...Aurobindo Pharma stock soared 4 percent to Rs 1,069 on March 2 after the pharma company received final approval from the US Food and Drug Administration to manufacture and market Fingolimod capsules, 0.5 mg, which are bioequivalent and therapeutically equivalent to the reference listed drug, Gilenya Capsules, of Novartis Pharmaceuticals Corporation. The product will be launched in March 2024... Full

Alembic Pharma Slashes the Price of Tofastar by 50% for Benefit of Rheumatoid Arthritis Patients

(3/4, Dr. Nandita Mohan, Medical Dialogues) ...One of the leading pharmaceutical majors in India, Alembic Pharmaceuticals Limited, has recently announced a 50% reduction in the prices of its Tofacitinib brand, Tofastar...In an endeavor to make Tofacitinib treatment more affordable, Alembic is now introducing Tofastar 5 mg tablets at Rs. 19 per tablet, which is almost a thousand Rupees for 4 weeks of therapy... Full

J&J Wins Ruling Blocking Tolmar's Copies of Schizophrenia Drug

(3/1, Christopher Yasiejko, Bloomberg Law) ...Johnson & Johnson's Janssen unit won a federal judge's ruling upholding a patent for its blockbuster schizophrenia drug Invega Sustenna and blocking Tolmar Inc.'s proposed copy until the patent's January 2031 expiration...Viatris Inc.'s Mylan unit and Teva Pharmaceutical Industries Ltd. are awaiting a decision in their consolidated appeal of a New Jersey federal judge's October 2021 ruling that upheld the patent's validity. Mylan agreed to be bound by the Teva case's final judgment and both companies conceded infringement ahead of trial... Sub. Req'd

Moving Biosimilars Forward in a Hesitant Market

(3/1, Feliza Mirasol, BioPharm International) ...There are 45 biosimilars approved in the United States, which represents amazing progress over the past 10 years or so, remarks John Gabrielson, senior vice-president at JSR Life Sciences and head of Similis Bio. Still, Gabrielson notes that the US lags roughly 10 years behind Europe in marketing biosimilars, with the first biosimilar, Zarxio (filgrastim-sndz), approved in the US in 2015. "We're looking at close to two decades now of experience worldwide with biosimilars," Gabrielson says. "I think we've come a long way. I think the market is extremely strong right now, but there are still some challenges."... Full

‘A Healthy Kid Dies and There Has Been No Change': Parents' Anger Over Lack of Warnings for Blockbuster Asthma Drug

(3/3, Jon Ungoed-Thomas, The Guardian) ...The US Food and Drug Administration found in review of data in 2008-09 a variety of adverse psychiatric events associated with the drug, including aggression, depression and suicidal behaviour. It said some reports appeared consistent with a drug-induced effect. The information leaflet for montelukast says suicidal thoughts and actions may be side effects, but are very rare. A review of 59 studies in report published in the European Respiratory Review last year did not find an increase in the risk of suicide of asthma patients taking the drug. Families say more research is required... Full

Change Healthcare Enables New Service Amid Outage

(3/1, Sriparna Roy, Reuters) ...UnitedHealth's unit Change Healthcare said on Friday it has enabled a new instance of its ePrescribing service for all its customers, more than a week after it reported a hack that had a knock-on effect on players across the U.S. healthcare system. "We have completed standing up a new instance of Change Healthcare's Rx ePrescribing service," the company said in an update on its status page... Full

US Judge Upholds Medicare Drug Price Negotiation Program

(3/1, Brendan Pierson, Reuters) ...A federal judge in Delaware on Friday upheld a law that requires some drugmakers to negotiate prices with the U.S government's Medicare health insurance program, rejecting a challenge by AstraZeneca to one of Democratic President Joe Biden's signature initiatives..."Today's ruling offers more reason for optimism that we will drive down the cost of prescription drugs in America," U.S. Secretary of Health and Human Services Xavier Becerra said in a statement... Full

Judge Denies AstraZeneca's Lawsuit Against Medicare Negotiation

(3/1, Joseph Choi, The Hill) ...In his opinion, U.S. District Judge Colm Connolly found that AstraZeneca had failed to properly establish its standing in filing a lawsuit against the federal government to block Medicare drug price negotiations. AstraZeneca filed a motion for summary judgment in September asking that the judge find the federal government's definitions of a "qualifying single source drug" and "bona fide marketing" under the Inflation Reduction Act to be contrary to the law... Full

NACDS: WH, CMS Action On PBMs, Legislative Reform Urgent

(3/1, Luke Zarzecki, InsideHealthPolicy) ...Ahead of a listening session President Joe Biden plans to hold Monday (March 4) on pharmacy benefit manager reform, the National Association of Chain Drug Stores is asking the White House to ramp up CMS' enforcement on PBM payment policies they describe as manipulations that harm pharmacies. NACDS also asks the White House for "vigorous encouragement and support" for congressional action on PBM reform... Sub. Req'd

On the Matter of Lower Prescription Drugs, White House Barks Up Wrong Tree

(3/4, Anthony LoSasso, RealClearMarket) ...University of Chicago economist Casey Mulligan has calculated that the full economic benefit of PBMs - via lower costs and improved health outcomes for American patients - adds up to $192 billion per year, and that efforts to limit PBMs' negotiation power would drive up Medicare Part D premiums by as much as 13.5%. These findings come against the backdrop of drug manufacturers launching new products in 2023 at prices 35% higher than just the previous year... Full

The ‘Pill Penalty' That's Worsening American Health

(3/2, James K. Glassman, The Hill) ...The gap — call it the "pill penalty" — is already having a big effect. By allowing four extra years to make back the $2 billion average cost of inventing a drug and bringing it to market, the government has made a biologic a much better place for risk capital than a pill. Eli Lilly CEO Dave Ricks said the difference "is about 50 or 60 percent of the value." He added, "In 10 years, we'll have far fewer small molecules being developed than we do today."... Full

Democrats Hauled in Innovators to Examine High Drug Prices; They Have The Wrong Culprit

(3/3, Jack Kalavritinos, NWI Times) ...If Congress wants to get serious about passing any meaningful legislation that will lower healthcare costs for patients, big insurer-PBMs should be first on their list for accountability and scrutiny before the public. PBM reform and de-linking PBM compensation from drug list price would be a great place to start. Sanders' attempt to place pharmaceutical innovators under the microscope backfired as attention was instead brought to the corporate middlemen who pocketed profits and hurt patients. It is hoped our lawmakers can rise above childish payback schemes — like demanding testimony from CEOs who disagree with their policies — to eradicate the rot in our health care system: big insurer-PBMs' shady practices... Full

How To Cut The Gordian Knot Of Drug Shortages

(3/3, Ge Bai, Forbes) ...The Food and Drug Administration has intensified its oversight efforts on drug safety. While ensuring drug safety is crucial, overregulation can have counterproductive effects and diminish patient utility. For manufacturers, the burden of heavy documentation and uncertainty about potential production suspensions entail high compliance costs, significant disruption risks, and low expected payoffs from maintaining, enhancing, or initiating production...The Gordian knot of drug shortages is created at least partially by government overreaction. More regulation will not bring relief. To cut the Gordian knot, manufacturers must be allowed to expect more benefit and less cost... Full

Approps Deal: FDA Must Shift Funds To Address Cosmetics, Product Shortages, Animal Testing Alternatives

(3/3, Jessica Karins, InsideHealthPolicy) ...FDA funding for fiscal year 2024 would be approximately level under a bicameral appropriations deal released Sunday (March 3), five months into the fiscal year, but the deal calls for the agency to reallocate at least $50 million to support specific priorities like cosmetics oversight, alternatives to animal testing, and mitigation of product shortages... Sub. Req'd

Generic Group Says FDA's Ophthalmic Guideline Should Align with ICH Q3B(R2)

(3/1, Joanne S. Eglovitch, Regulatory Focus) ...The Association for Accessible Medicines objects to the higher impurity threshold limits set in the US Food and Drug Administration's revised draft guidance on quality considerations for topical ophthalmic drugs and said that failure to align these limits with the International Council on Harmonisation's Q3B(R2) guideline could jeopardize the development of these products... Full

Drug Makers Look To Simplify Application Process With New ICH Guidance On Platform Methods

(3/1, Bowman Cox, Pink Sheet) ...As ICH member countries prepare to implement Q2(R1)/Q14 guidelines, industry is focusing on provisions in both for platform analytical procedures, which applicants for drug approvals and biologics licenses could use to reduce method validation requirements. Pfizer undertook the first commercial application of the platform analytical approach, which is widely used in development... Sub. Req'd

Generic Drug Cluster: What Are Global Regulators Discussing?

(3/1, Urte Fultinaviciute, Generics Bulletin) ...In its ongoing attempt to embrace international harmonization, the US Food and Drug Administration invited stakeholders from both sides of the Atlantic to discuss how global health regulators can join forces to improve generic drug development at a recent webinar on "Expanding Generic Drug Access Through International Engagements."... Global Sub. Full

FDA Stresses Need To Educate Pharmacists NTI Generics Are Safe

(3/1, Jessica Karins, InsideHealthPolicy) ...The Center for Drug Evaluation and Research published a blog post Monday (Feb. 26) on its process for evaluating the small set of drugs with a small therapeutic window, which require more careful consideration of the appropriate dose. The post features comments from Liang Zhao, director of the Division of Quantitative Methods and Modeling in the Office of Generic Drugs, and Mehul Mehta, of the Division of Neuropsychiatric Pharmacology in the Office of Translational Sciences... Sub. Req'd

AG Ferguson, Legislature Get Tough On Price-Fixing, Other Antitrust Violations

(3/1, Washington State Attorney General Bob Ferguson) ...With the passage of House Bill 2072, Washington increases the maximum civil penalty for price-fixing, collusion and other antitrust violations to three times the unlawful gains or loss avoided. Prior to the passage of this bill, Washington's antitrust penalty lagged far behind other states and did not provide meaningful deterrence for unlawful conduct by large corporations. The maximum penalty was $900,000 - even if the price-fixing conspiracy netted tens of millions of dollars in profit... Full

As An Opioids Scourge Devastates Tribes in Washington, Lawmakers Advance a Bill to Provide Relief

(3/1, Hallie Golden, Associated Press) ...A bill that would bring millions of dollars to tribes in Washington state to address the opioid crisis received unanimous support in the House on Friday, opening the door for state funding to address a scourge that some say is claiming a generation...The proposed measure is expected to provide nearly $8 million each year for the 29 federally recognized tribes in Washington, funds drawn in part from a roughly half-billion-dollar settlement between the state and major opioid distributors... Full

State Lawmakers Take Up Bills Aiming to ‘Revolutionize the Insulin Market'

(3/4, Mark Sanchez, Crain's Grand Rapids Business) ...Lawmakers in Lansing began considering bills last week that would allow the state to partner with a private manufacturer to produce and distribute low-cost generic insulin...Backers of the bipartisan bills say a public-private partnership could produce and sell generic insulin that costs far less than what consumers pay today... Full

Sandoz and Global Generics Industry Call for Bold, Coordinated Global Action to Ensure Sustainability of Critical Antibiotics

(3/1, Sandoz) ...The AMR Industry Alliance, the largest industry group dedicated to combatting the spread of antimicrobial resistance (AMR), this week launched a formal call to action at a key meeting in New York, ahead of the UN High-Level Meeting on AMR later this year...Speakers at the event, including Sandoz Global Anti-Infectives and B2B head Ian Ball, called on the UN meeting in September to include ambitious and measurable actions in their planned High-level Declaration on AMR, with a balance approach across the four strategic pillars of Responsible Manufacturing, Responsible Access, Responsible Use and Innovation... Full

European Off-Patent Industry Welcomes Unitary SPC Pre-Grant Opposition

(3/1, David Wallace, Generics Bulletin) ...Medicines for Europe has welcomed the European Parliament's "balanced stand on unitary supplementary protection certificate regulation," after the Parliament endorsed provisions that included allowing pre-grant opposition. The approach – which the off-patent industry association said "rewards innovation via an efficient unitary SPC system that protects against access to medicines delays" – had been controversial, facing protests from the likes of the European People's Party and the German Federal Council, or Bundesrat... Global Sub. Full

Three Major Regulators Launch Pilot To Reduce Duplication Of GMP Inspections

(3/1, Ian Schofield, Pink Sheet) ...Regulatory bodies from Australia, Canada and the UK say a new pilot program will reduce the need for multiple inspections of the same site, while an MoU signed by Australia and Canada will cut the amount of documentary evidence required from drug sponsors seeking GMP clearances... Sub. Req'd

Amgen Wins First Approval Through UK's New International Recognition Procedure

(3/1, Eliza Slawther, Pink Sheet) ...A line extension for Amgen's Xgeva (denosumab) was granted by the UK's Medicines and Healthcare products Regulatory Agency using its newly-launched International Recognition Procedure, marking the first authorization made under the scheme...It said that its review took 30 days and that it considered the EMA assessment "as part of its own review," which facilitated a "rapid approval process."... Sub. Req'd

NZ Govt Moves To Speed Drug Access Amid Plans To Wipe Out Major New Act

(3/1, Neena Brizmohun, Pink Sheet) ...Streamlined assessments that New Zealand's regulator and health technology assessment body offer for cancer drugs are being expanded to cover medicines in all therapeutic areas, says the new coalition government, which plans to repeal the landmark Therapeutic Products Act that was passed last year. HTA body Pharmac is to assess funding applications for all new medicines that are still being evaluated for marketing authorization by the drugs regulator, Medsafe, so that products can be considered for funding more quickly, the government said on February 28... Sub. Req'd

NPPA Fixes Retail Prices of 70 New Drug Formulations

(3/2, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority has fixed retail prices of 70 new drug formulations including antidiabetes, anti-hypertension, antibiotics and pain killers among others, for the companies which have applied for price fixing under Form I of the drug price regulations... Full

Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'

(3/4, Anju Ghangurde, Pink Sheet) ...Lilly's CEO indicates that the long-standing IPR debate that has generally divided the developed and developing world is largely a "false narrative." The executive also called for lowering regulatory barriers in India amid expectations of the potential debut of Zepbound/Mounjaro in the country next year. Tirzepatide may be on course to India but Eli Lilly and Company's CEO, David Ricks, made clear that the enabling intellectual property rights environment in the country isn't quite optimal... Sub. Req'd

Indian API Industry Sees Make in India and PLI to Curtail Imports from China

(3/4, Pharmabiz.com) ...According to Rakesh Reddy, managing director, Aparna Pharmaceuticals, the implementation of the PLI scheme, coupled with a strategic industry perspective aimed at decreasing reliance on China, is motivating Indian API companies to localise production of intermediates and KSMs (key starting materials) while enhancing their competitive edge in the foreseeable future. Overall, this scheme encourages innovation and collaboration... Full

Biocon Biologics Gets Green Light to Launch Yesafili Biosimilar in Canada

(3/4, Anjali Singh, Business Standard) ...Biocon Biologics, a subsidiary of Biocon, on Monday officially announced a settlement with Bayer and Regeneron Pharmaceuticals. This agreement allows Biocon Biologics to launch Yesafili, a proposed biosimilar to EYLEA (aflibercept) Injection, in the Canadian market. Under the agreement, Biocon Biologics will launch Yesafili no later than July 1, 2025. Health Canada had granted tentative approval for Yesafili in March 2023... Full

JAMP Pharma Group Announces the Commercial Launch and Product Availability for PrJamteki™, The First Biosimilar of Stelara® (Ustekinumab) in Canada

(3/1, JAMP Pharma Group) ...JAMP Pharma Group, a Canadian-owned pharmaceutical organization headquartered in the Greater Montreal area, announced today the commercial launch and product availablity for JamtekiTM, a biosimilar of Stelara® (ustekinumab). The currently approved presentations of Jamteki TM are the 45mg/0.5mL pre-filled syringe with passive safety device for subcutaneous injection (PFS-SD) and the 90mg/mL PFS-SD. This is the second JAMP Pharma biosimilar to receive marketing authorization. In 2022, JAMP launched Simlandi®, a biosimilar of Humira® (adalimumab)... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.