Novartis melanoma combination wins key thumbs-up from cost watchdog NICE after Opdivo shut out

Just one week after Bristol-Myers Squibb failed to gain a recommendation for coverage in the U.K. for Opdivo in adjuvant melanoma, Novartis has one-upped its rival with an approval in the same setting.

The National Institute for Health and Care Excellence (NICE) has given its blessing to the combination of Novartis’ Tafinlar and Mekinist in patients with stage III BRAF V600 mutation-positive melanoma after surgery. The agency cited a lack of adjuvant treatment options and the effectiveness of the combination in lowering the chance of the cancer spreading. The decision comes two years after NICE recommended the combination as a first-line treatment for advanced melanoma patients who are not eligible for surgery.



Italian CDMO buys India API plant that supplies Novartis

CDMO Olon is continuing its expansion binge with a deal to buy an API plant in India that supplies ingredients to Novartis.

The Italian generic drug and API maker said Tuesday that it is buying an API manufacturing facility in Mahad, India, that supplies ingredients to Sandoz, the generics division of Novartis. Olon said that as part of the purchase agreement, it has committed to a long-term supply contract to supply the Sandoz products manufactured in Mahad. Sandoz closed a plant in Mahad in 2016.

It said no jobs would be lost and that Olon intends to invest in the site, which also provides drugs to the Indian healthcare system. Terms of the deal were not disclosed.

“By acquiring a manufacturing base in India, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to develop new generic products for the Indian market,” Olon CEO Paolo Tubertini said in a statement. “It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements. (cr: FiercePharma)


Child ingests antipsychotic drug, leading Novartis to recall packages that don’t meet child safety rules

Novartis and its generics unit Sandoz are voluntarily recalling nearly half a million packages of medications after a child opened a “child-proof” blister pack and ingested a tablet of antipsychotic medication haloperidol.

The recall of 470,000 packages of a variety of drugs was announced Friday by the Consumer Product Safety Commission, which said, “The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.”

It didn’t say how, or if, the child was affected. A Novartis logo is pictured on its headquarters building in Mumbai

Kymriah approved for treatment of lymphoma

Recently, the US FDA approved tisagenlecleucel (Kymriah) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and In DLBCL caused by follicular lymphoma (FL), these patients have undergone two or more systemic treatments. Kymriah, is a treatment for B-cell acute lymphoblastic leukemia which uses the body’s own T cells to fight cancer (adoptive cell transfer).

“Kymriah aims to provide doctors with a therapy that can exhibit long-lasting response in patients with relapsed or refractory DLBCL who have undergone multiple rounds of chemotherapy, many of which have also experienced failed stem cell transplantation.” Dr. Stephen J. Schuster, professor of the University of Pennsylvania School of Medicine and director of the lymphoma project at the Abramson Cancer Center, said in a statement: “With this approval, doctors now have a meaningful treatment option that can achieve and maintain long-term treatment efficacy without need for stem cell transplantation, and the treatment is safe  and stable.”

We congratulate Novartis and hope that this therapy will bring long-lasting improvement to patients with lymphoma.


Novartis puts $100 million into malaria R&D

Novartis will spend more than $100 million over five years to develop new treatments for malaria. The funds will support clinical trials for two antimalarial drug candidates, KAF156 and KAE609, which are both in midstage clinical studies. Malaria deaths have dropped by 60% between 2000 and 2015. But the infection continues to kill more than 400,000 people each year. Novartis says it will make the drugs affordable in the countries that need them the most. (See more details on c&en)


Novartis to expand gene therapy pipeline with acquisition of AveXis for $8.7 billion

Novartis plans to acquire the neurological gene therapy firm AveXis for $8.7 billion. The purchase will bolster the Swiss giant’s standing as a big pharma leader in the emerging gene therapy field.

AveXis’s leading drug candidate is its gene therapy to treat infants with spinal muscular atrophy type 1 (SMA1), a devastating genetic disease, sometimes called “floppy baby syndrome,” that causes weak muscles and difficulty breathing. Only 8% of afflicted infants survive to 20 months of age. Those that do rely on ventilation support and will never walk.


Chinese Premier plans ‘zero tariff’ on imported cancer drugs

Chinese premier Li Keqiang said China will nix import tariffs on foreign anticancer drugs, a plan that could benefit drugmakers like Roche, Novartis and AstraZeneca, while prompting local pharmas to amp up their games.

“We aim to further bring down overall tariffs across the importing process, with tariff rates for important day-to-day consumer goods, including drugs, slashed. And we also plan to phase in zero tariff for the much-needed anti-cancer drugs,” said Li during a televised press conference at the close of the country’s annual congress conference on Tuesday.

Without providing a detailed timeline, Li also said the country will open up further to stimulate market vitality and public creativity.