Keeping tabs on pharma: First diabetes pill for pregnant women approved

Merck’s first oral diabetes drug for pregnant women

Science and technology company Merck has announced the approval of metformin for use by pregnant women with diabetes.

Sold under the brand name Glucophage, it is the first ever oral treatment for pregnant women with diabetes, providing an alternative for those who are not able to, or do not want to have daily insulin injections. 

The drug’s approval follows a European study that investigated the outcomes of metformin in approximately 4,000 pregnancies, following up with children for up to 11 years after their birth. There was no increased risk of congenital abnormalities or toxicity after exposure to metformin, whether at the time of conception or throughout pregnancy.

The research also found that metformin was comparable to insulin in reaching maternal blood sugar control and better than insulin at controlling pregnancy weight gain.

Maria Rivas, SVP and Chief Medical Officer at Merck commented: “During pregnancy and when wanting to become pregnant, good glycemic control is of utmost importance, as insufficient glycemic control leads to a three times higher risk of pregnancy loss than in normoglycemic women. The estimated risk of malformation is doubled.

"Until now, pregnant women were required to use insulin to control their blood sugar during this period. The label extension now opens a tablet alternative to women who are not able or wanting to use daily injections.” 

Entering Africa’s pharmaceutical cannabis market

UK-based medical cannabis company Apollon Formularies has announced a deal that will target the African cannabis market for the first time.

The deal with Tri-Medi Canna will give Apollon an additional avenue to monetize its proprietary medical cannabis. Tri-Medi Canna will benefit from Apollon’s exposure to European markets, while engaging with the South African Government to boost cannabis research at the University of Kwazulu Natal.

Apollon has stated that this partnership will help them establish a strong foothold in Africa, “the last remaining significant region of pharmaceutical growth globally.”

Thokozani Shongwe, CEO of Tri-Medi Canna, said: “We are delighted to be working with Apollon Formularies as we expand our offering across South Africa and grow our knowledge and skill base through this partnership.

"Apollon has forged firm routes in Jamaica and its proprietary formulas have consistently proven to be effective during rigorous testing on pre-clinical third-party pharmaceutical laboratory testing conduced in the US on 3D Cell cultures” Shongwe added. 

Brexit hinders medical device market, report finds

A new report has found that 60 percent of medical device manufacturers believe Brexit will make marketing new products more difficult in the UK.

The Brexit transition is adding paperwork and costs that are burdening the medical device industry, according to GlobalData.

Selena Yu, Medical Devices Analyst at GlobalData, said: “The approval and marketing processes of new medical devices are expected to become more complex and lengthier because manufacturers need to follow both EU and UK regulation.

"In the end, companies will need to increase spending to release and market new products to the UK" she added. "This additional barrier may simply deter companies from selling their medical devices in the region, as they turn instead to focus on the already established EU relationship.”

Also in the news:

• The Sackler family, owners of Purdue Pharma, have reached a deal to pay up to US$6bn in cash to resolve the lawsuit alleging they fueled the US opioid epidemic.
• Bayer is investing US$1.55bn in the digitization of five of its German production sites, focusing on advanced technologies including artificial intelligence and automation.

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