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.

Novartis blazes Big Pharma trail, striking deal with Canadian company to distribute medical marijuana products

In what may be the first foray by Big Pharma into the sale of medical marijuana products, Novartis has struck a deal with a Canadian company that sells medical cannabis products not only in its home country but also in Europe.

Nanaimo, British Columbia-based Tilray announced today that it has a binding agreement with Sandoz Canada to be its exclusive supplier of “non-smokable/non-combustible medical cannabis products.”

“We are thrilled to form a strategic alliance with Tilray to strengthen our portfolio,” Michel Robidoux, president and GM of Sandoz Canada, told the newspaper in a statement. “We are committed to making every reasonable effort to respond to patients’ medical needs by increasing the number of high-quality, adequately dosed non-smokable, non-combustible medical cannabis products at the disposal of doctors.”

Novartis will use its expertise to educate pharmacists about the products and to help Tilray develop new products and dose forms.

Tilray cannabis products

cr: FiercePharma

Novartis wins FDA nod for newly acquired cancer drug Lutathera

Just months after picking up Advanced Accelerator Applications in a $3.9 billion buyout, Novartis is getting a quick boost with the U.S. approval for Lutathera. The FDA approved the first-in-class med as a treatment for rare cancers of the digestive tract the other day.

Lutathera is first the peptide receptor radionuclide therapy to win U.S. approval, according to a release from AAA. Approved to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the drug works by binding to the receptors and then using radiation to fight cancer.

Jefferies analysts have predicted $500 million to $1 billion in peak sales for the drug, while Baader Helvea analyst Bruno

NovartisBulic has been more optimistic. At the time of the AAA acquisition by Novartis last year, he predicted $2 billion in peak sales, according to Reuters.