Food and Drug Administration (FDA) has approved EPKINLY (epcoritamab-bysp), as the T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies.

EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, comprising of an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.

"DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."

EPKINLY marks the third approved blood cancer treatment available as part of AbbVie's growing oncology portfolio.

"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," said Tycel Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. "Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."

"The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

Read also: AbbVie plan to withdraw accelerated nods of Imbruvica in US for patients with certain types of blood cancer

AstraZeneca decided not to continue its membership after a recent assessment of whether it was "the most productive and effective use of (company) resources," a spokesperson for the British drugmaker said in an emailed statement.The news, first reported by Politico, marks the trade body's third major departure in six months. AstraZeneca's exit follows those of AbbVie, maker of blockbuster arthritis drug Humira, and Teva, a leading manufacturer of generic drugs.Read also: AbbVie to exit leading US drug industry trade groupAstraZeneca will redirect the funds previously used on its PhRMA membership to continue U.S. advocacy efforts with state and federal policymakers, the statement read.PhRMA did not respond immediately to an emailed request for comment outside business hours.The U.S. is the largest national market for all big pharma companies. Drugmakers suffered a rare defeat last year in failing to stop the Inflation Reduction Act, which allows the government to negotiate prices on certain drugs.

In February, the company raised doubts about its ability to remain in business, due to uncertainty about 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects.

The Maryland-based drugmaker on Tuesday also unveiled promising early data for its COVID and flu combination vaccine.

It said it now expects 2023 revenue between $1.4 billion and $1.6 billion, compared with analysts' estimates of $831.6 million, according to Refinitiv data.

Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year.

Jefferies analyst Roger Song said the amount of overseas revenue flagged by the company was a surprise to the market, and the roughly $260 million to $440 million they expect in the U.S. was also encouraging.

"They seemed to be very confident about the U.S. fall campaign," Song said.

Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Protein-based vaccines like Novavax's take longer to produce than the messenger RNA-based versions made by Moderna and Pfizer /BioNTech.

Chief Executive John Jacobs declined to disclose the company's U.S. pricing strategy as the country moves to a commercial marketplace for COVID products from government purchases when the pandemic was designated a public health emergency.

"Obviously, it's a really competitive marketplace. We're coming in as a late follower with two competitors that were entrenched in the U.S. market already," Jacobs said in an interview. "We're assessing what the competitors are doing and we'd rather unveil our cards a little bit later."

The company said it plans to layoff around 20% of its nearly 2,000 full-time employees, close to 400 jobs. The remaining job cuts will be contractors, it said.

Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year.

Its cash and equivalents fell to $637 million at quarter-end from $1.3 billion as of Dec. 31.

Novavax posted a first-quarter net loss of $3.41 a share, compared with estimates for a loss of $3.46 a share.

All the COVID vaccine makers are working on COVID-flu combination shots with the aim of expanding and picking up market share in what they hope will be an annual booster market.

Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

Read also: Novavax cut USD 50 million in costs, plans to slash more: CEO

The U.S. Court of Appeals for the Federal Circuit agreed with a Delaware federal court that UCB's patent on Neupro patches was invalid. A ruling for UCB could have delayed U.S. Food and Drug Administration approval of a Neupro generic until it expired in December 2030, the court said.An earlier court order based on a separate patent had blocked Actavis' proposed generic until 2021.A Teva spokesperson said the company was pleased with the decision. Representatives for UCB and Viatris did not immediately respond to requests for comment.The FDA first approved Neupro in 2007 to treat Parkinson's disease, a neurodegenerative disorder. It was removed from the market in 2008 over dosing concerns and reapproved with a different formula in 2012.UCB sold over 300 million Euros worth of the drug worldwide last year, according to a company report.UCB and LTS Lohmann Therapie-Systeme AG sued Actavis and Mylan for patent infringement in 2019 over their planned Neupro generics. A Delaware court invalidated UCB and LTS' patent in 2021 based on their earlier patents for the original version of Neupro that the court said covered the same invention.Read also: Biocon partner Viatris gets Complete Response Letter from USFDA for Bevacizumab license applicationThe Federal Circuit affirmed Wednesday that the patent UCB accused Actavis and Mylan of infringing was obvious and unpatentable.The case is UCB Inc v. Actavis Laboratories UT Inc, U.S. Court of Appeals for the Federal Circuit, No. 21-1924Read also: Cipla, Aurobindo, Viatris in licensing pact with MPP to produce generic versions of ViiV Healthcare HIV drug

The agency's decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie Inc, Pfizer Inc and Johnson & Johnson.

The health regulator cited issues related to the proposed manufacturing of the drug, mirikizumab, although it did not express concerns about the clinical data package, safety, or label for the medicine, Lilly said.

The company also said it was confident in the late-stage data of the drug, which was pegged among Lilly's potential growth drivers for this decade, and was working with the FDA to address the issue.

"The setback is fairly minor from the context of what a great portfolio Eli Lilly has and even within the drug itself, it sounds like it's manufacturing issues, so I don't think that's going to be overly problematic," Morningstar analyst Damien Conover told Reuters.

Eli Lilly was seeking approval for the drug as a treatment for ulcerative colitis, which is a condition where abnormal reactions of the immune system cause inflammation and ulcers on the inner lining of the colon, possibly leading to diarrhea, passing of blood with stool and abdominal pain.

"There is still possibility this product can exceed $2 billion peak sales," Wells Fargo analyst Mohit Bansal said in a note.

Earlier this year, the health regulator had declined an accelerated nod for Lilly's Alzheimer's disease drug, donanemab, potentially preventing the company from expediting the launch.

Read also: USFDA rejects accelerated approval for Eli Lilly Alzheimer's drug Donanemab

The drugmaker's other anticipated launches in 2023 include tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and cancer drug pirtobrutinib.

Other approved indications for IMBRUVICA in the U.S. are not affected. This voluntary action is due to requirements related to the accelerated approval status granted by the U.S. FDA for MCL and MZL. These indications were approved via this pathway based on overall response rates in Phase 2 clinical studies. To confirm clinical benefit following accelerated approvals, additional studies are required by the FDA.The Phase 3 SHINE (NCT01776840) study in previously untreated MCL and the Phase 3 SELENE study (NCT01974440) in relapsed or refractory MZL served as confirmatory studies. The SHINE study met its primary endpoint of progression-free survival. The addition of IMBRUVICA to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm. The SHINE study results were presented during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and were published in The New England Journal of Medicine. The SELENE study did not meet its primary endpoint of progression-free survival. The SELENE study results will be presented at a future scientific forum.IMBRUVICA's established clinical profile in other approved indications is unchanged and the medication remains the most comprehensively studied and prescribed cancer treatment in its class. IMBRUVICA remains an important therapy for patients and healthcare professionals around the world.“We pursued accelerated approvals for MCL and MZL indications for IMBRUVICA in the U.S. to offer a treatment to patients who at the time had limited therapeutic options. While we are disappointed in the outcome of the confirmatory trials for these indications, we remain confident in the benefit/risk profile of IMBRUVICA for patients living with multiple forms of blood cancer around the world,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie."AbbVie fully supports the FDA accelerated approval process and is working with the FDA to complete these withdrawals," the company stated.Read also: AbbVie gets positive EMA committee opinion for Upadacitinib to treat adults with moderate to severe Crohn's disease

The drugmaker's shares were down nearly 1% at $159.50 in extended trade.

The company estimated first-quarter adjusted earnings to be between $2.31 and $2.41 per share from an earlier range of $2.39 to $2.49.

It now sees 2023 adjusted earnings to be between $10.62 and $11.02 per share, compared with its prior forecast of $10.70 to $11.10.

Analysts on average were expecting full-year earnings of $11.07 per share, according to Refinitiv IBES data.

Read also: AbbVie gets positive EMA committee opinion for Upadacitinib to treat adults with moderate to severe Crohn's disease

AbbVie is scheduled to report first-quarter earnings on April 27.

The company said in February that it expects sales of its flagship rheumatoid arthritis drug Humira to decline 37% this year due to competition from cheaper biosimilars in the United States, but sees that stabilizing by the end of 2024

Read also: USFDA refuses to approve AbbVie Parkinson's disease therapy ABBV-951, seeks more information

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc.

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Brimonidine Tartrate Ophthalmic Solution, 0.15% has an estimated market size of US$ 97 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.

Medical Dialogues had earlier reported that the company had received final approval from the USFDA for its ANDA Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg.

Read also: Alembic Pharma Hypertension drug Prazosin Hydrochloride gets USFDA okay

Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.

Read also: Alembic Pharma successfully completes ANVISA, Brazil GMP audit for API-III facility at Karakhadi

Analysts said that while Alameda County Superior Court Judge Evelio Grillo's ruling was not surprising, the litigation will likely weigh on the drugmaker's share price until the trial, scheduled to begin July 24. The trial will be the first test of how Zantac cancer claims will fare before a jury. The plaintiff, California resident James Goetz, says he developed bladder cancer from taking the drug."Our client will now have his day in court, and we look forward to sharing the evidence with the jury that GSK has known for decades that Zantac contains staggering amounts of a proven carcinogen," Jennifer Moore, a lawyer for Goetz and others suing over Zantac, said in a statement.GSK said in a statement it disagreed with the ruling and would defend the case at trial. The company has repeatedly denied that Zantac can cause cancer.First approved in 1983, Zantac became the world's best selling medicine in 1988 and one of the first-ever drugs to top $1 billion in annual sales.Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer, Boehringer Ingelheim and finally Sanofi. Those companies also face lawsuits over the drug.The companies scored a major victory in December, when a federal judge threw out all of the Zantac cases in U.S. federal court, some 50,000, after finding the opinions of the plaintiffs' expert witnesses linking the drug to cancer were not backed by sound science.In 2019, some manufacturers and pharmacies halted Zantac sales over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts.The FDA in 2020 pulled all remaining brand name Zantac and generic versions off the market, triggering a wave of lawsuits.Analysts said it was not surprising that Grillo ruled differently from the federal court because California's courts are known to be friendlier to plaintiffs."We've had some (investor) feedback who are disappointed here given that they were hoping a settlement would have been more likely," said Barclays analyst Emily Field. "This obviously removes the blue sky scenario of the case being totally thrown out, but really that wasn't people's expectation."Citi analysts said the likely magnitude of any settlement for GSK is "likely very modest", at less than $5 billion, and noted that the statute of limitations will somewhat restrict a mushrooming of casesRead also: Heartburn drug: Sanofi expects decision on Zantac dispute with Boehringer in Q1 at earliest

The therapy, ABBV-951, is a formulation of carbidopa-levodopa, the standard of care for the disease. It is administered subcutaneously, or under the skin, through an infusion pump.

The company's application was based on data that showed the therapy significantly extended the time that patients did not observe involuntary movement, compared to orally administered carbidopa-levodopa.

Parkinson's disease causes unintended or uncontrollable movements and is characterized by "off" periods in patients under therapy for a long period.

The U.S. health regulator has not sought additional efficacy and safety trials, the company said, adding it plans to resubmit the marketing application as soon as possible.

Read also: AbbVie raises sales outlook of Skyrizi, Rinvoq to USD 17.5 billion in 2025

Evercore ISI analyst Gavin Gartner said it was an unfortunate decision as the therapy could possibly be one of AbbVie's biggest new product launches over the next year or two.

Analysts have forecast sales of $1.3 billion for AbbVie's therapy in 2028, according to Refinitiv data. The company's shares were marginally lower in morning trade

Read also: AbbVie gets positive EMA committee opinion for Upadacitinib to treat adults with moderate to severe Crohn's disease