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Cardinal Health settles painkiller probe; R&D proving costly to drugmakers


Essential IR Insights Newsletter Fall - 2023

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Cardinal Health settles painkiller probe; R&D proving costly to drugmakers

* The world's biggest pharmaceutical companies are focusing more on drugs from their own labs as they grapple with declining yields of their research and development efforts. An analysis by Deloitte projects large drug makers will generate more future revenue from treatments developed internally than those acquired or in-licensed from the outside.

* Cardinal Health Inc.'s drug distribution business, Kinray LLC, will pay $10 million to settle a painkiller shipment claim in the U.S., Reuters reported. The settlement stems from Kinray's failure to alert the U.S. Drug Enforcement Administration of "suspiciously large" orders of opioid painkiller Oxycodone by more than 20 pharmacies in New York.

* In other news, India's National Drug Pricing Regulator capped the prices of over 50 essential drugs resulting in a price cut of between 5% to 44% in treatments of HIV, diabetes, bacterial infections and angina, the Economic Times reported.

* Doctors and aid organizations in India are also attempting to curb what they say is a monopoly on the sale of GlaxoSmithKline PLC's recently approved HIV drug Dolutegravir, the Economic Times reports. Based on existing agreements with the company, only Emcure Pharmaceuticals is authorized to sell the drug in the Indian market, prompting activists to call on the Competition Commission of India and the National Pharmaceutical Pricing Authority to take action.

Drug and product pipeline

* The U.S. FDA withheld approval of Amphastar Pharmaceuticals Inc.'s Primatene Mist asthma inhaler, asking the pharmaceutical company to make further changes to the label and packaging while conducting another study to determine whether consumers can use the product without doctor or pharmacist help.

* Meanwhile, Shire PLC's Adynovate nabbed U.S. FDA approval for the treatment of hemophilia A in patients younger than 12 years.

* Lupin Ltd.'s Olmesartan Medoximil tablets were tentatively approved by the U.S. FDA as a generic of Daiichi Sankyo Co. Ltd.'s Benicar tablets. The drug is indicated for the treatment of hypertension and blood pressure.

* Glenmark Pharmaceuticals Ltd. secured the U.S. FDA's approval for Tretinoin capsules to treat acute promyelocytic leukemia. Tretinoin is a generic version of Hoffman La Roche Inc.'s Vesanoid capsules.

* The U.S. FDA granted priority review to Portola Pharmaceuticals Inc.'s new drug application for betrixaban. The drug is used in patients with risk factors for venous thromboembolism, the obstruction of blood vessels.

* Biogen Inc.'s Spinraza received U.S. FDA approval for the treatment of spinal muscular atrophy. The drug showed improvements in patient motor functions during clinical trials.

* Aerie Pharmaceuticals Inc. expects to resubmit the new drug application for Rhopressa eye drops near the end of the first quarter of 2017. The company received notification from its third-party manufacturing vendor that the manufacturing line related to Rhopressa in their Tampa, Fla., facility will not be ready for pre-approval inspection by the U.S. FDA until the end of February 2017.

Operational activity

* Marubeni Corp. plans to form a pharmaceutical and related products distribution business with Shanghai Fosun Pharmaceutical (Group) Co. Ltd. The companies are considering a joint venture that would supply Japanese pharmaceuticals in China and Chinese pharmaceutical raw materials and product copies in Japan.

* Sinovac Biotech Ltd. plans to investigate allegations that its Chairman and CEO Yin Weidong paid bribes to the former deputy director general of the Center for Drug Evaluation under the China Food and Drug Administration.

* Sun Pharmaceutical Industries Ltd. bought $13 million worth of scPharmaceuticals Inc. series B preferred stock which can be converted into shares representing 14.6% of the company, the Press Trust of India reports.

* Strongbridge Biopharma PLC acquired the U.S. rights to Keveyis from a unit of Taro Pharmaceutical Industries Ltd. The drug is used to treat hyperkalemic, hypokalemic and related variants of primary periodic paralysis.

* Zoetis Inc. secured a $1 billion revolving credit facility from a syndicate of banks represented by JPMorgan Chase Bank NA. The new facility will replace the company's existing credit line.

* Meanwhile, Dynavax Technologies Corp. is no longer issuing $100 million worth of debt to Deerfield Management Co. LP and its affiliates.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Nikkei 225 rose 0.03% to 19,403.06. In Europe, around midday, the Euronext 100 was up 0.28% to 932.74.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.