💊 Roche goes shopping in China; Gilead’s foray into oncology and inflammation; The state of global pre-term births, by the WHO

#337 | Amgen scans Crohn’s disease targets; CEPI’s need for speed; Indian pharma in Mexico

Hello and welcome back to The Kable for another busy day in the life sciences.

Today, we’re kicking things off with news of Roche shelling out $70 million for ZN-A-1041, an oral HER2-targeting tyrosine kinase inhibitor from China’s Zion Pharma. The drug candidate, with the potential to treat or prevent brain metastases, is currently in phase 1 trials.

Gilead Sciences has acquired the San Diego-based biotech XinThera and its pipeline of experimental drugs in the therapeutic areas of oncology and inflammation. XinThera’s early stage drugs mainly block the proteins PARP1 or MK2. But how much exactly these drug candidates are worth, the companies have not disclosed.

With an upfront payment of $30 million, Amgen has entered a deal with TScan Therapeutics. The two companies will work collaboratively to discover new targets for Crohn’s disease; Amgen has the option to bring ulcerative colitis into the picture as well. In total, the deal could be worth up to $530 million.

Meanwhile, India’s Bharat BioTech and Serum Institute are in conversation with the Mexican government to expand their presence in the LatAm region.

No RSV at-home test exists currently. But that could change soon as Cue Health has made a de novo submission to the US FDA for its RSV molecular test.

AstraZeneca also has some good tidings from the FDA as the agency approved the company’s Farxiga – an oral SGLT2 inhibitor – for a label extension to include the reduction in risk of cardiovascular death and hospitalization for heart failure.

Gilead saw victory in court yesterday, as a federal jury ruled in its favour in a long-running patent battle with the US government over the use of HIV drugs Truvada and Descovy for pre-exposure prophylaxis.

Meanwhile, Novavax spoke of mid-stage results for three of its vaccines, one of which is a combo shot for Covid and the flu. All of them demonstrated safety and strong immune responses.

But a this success is no reason not to lighten up. As Covid vaxx sales fall, Novavax is cutting its 1,992-stong workforce of full-time employees by 25%.

And its friends in the industry are taking a cue as well. Cue Health is bidding bye-bye to 326 employees, or 30% of its workforce, in its second round of layoffs this year. Bristol Myers Squibbis laying off 48 people in New Jersey, while Takeda is letting go of 180 workers in Massachusetts.

Following inspections of Eli Lilly and Rentschler Biopharma’s production facilities late last year and early this year, the FDA’s Form 483 filings raised concerns about how aseptic procedures were carried out.

But the FDA is now sick and tired of how many warning letters and Form 483s it has had to hand out in the recent past. Yesterday, the agency released new guidance, for immediate implementation, on the testing of glycerin and other chemicals with the potential of contamination by diethylene glycol (DEG) and ethylene glycol (EG). This new 11-page guidance alerts manufacturers, suppliers and others involved in the supply chain about the hazards of contaminated glycerin and other chemicals. DEG and EG are the same contaminants that were implicated in the deaths of children in the Gambia, Uzbekistan and Indonesia from substandard cough syrup consumption. No such DEG- or EG-contaminated products have entered the US yet, but the FDA remains on alert.

The WHO has released two new reports – Right to Health 2019 to 2021 and Palestinian Voices 2022 to 2023 – illustrating how the conflict in the region is causing health inequities and barriers to health care provision in the West Bank. As per the reports, only 55% of essential medicines were available in the Central Drugs Store of the Ministry of Health in the Gaza Strip from 2019 to 2021. In the same time period and region, 35% of permit applications by patients were not approved in time for them to make it to their hospital appointments.

Over in Africa, eHealth Africa is working with the Solina Center for International Development and Research to support other stakeholders in the polio outbreak response focused in 7 states of Nigeria. eHealth Africa will provide GIS tracking support to vaccination teams as they bring the polio vaccine to security-compromised and partially-accessible settlements.

In Argentina, healthcare workers are protesting in cities of the Santa Fe province to demand better pay.

In Indonesia, an outbreak of African swine fever has been confirmed on a farm near Singapore, according to the World Organisation for Animal Health. As if poultry shortages were not sad enough, now we have to worry about pigs being in short supply too.

In Bangladesh, 21 more people have been hospitalized with dengue in the 24 hours leading up to yesterday morning. This brings the country’s total number of currently hospitalized dengue patients to 77.

In Pakistan, the Congo virus has claimed its first victim this year.