Gates backs de­vel­op­ment work on a long-act­ing con­tra­cep­tive pill

The risk of preg­nan­cy is much low­er for women who take their oral con­tra­cep­tive pill cor­rect­ly — every day at about the same time. In the Unit­ed States, the pills are not avail­able over the counter, and these fac­tors con­tribute to poor med­ica­tion ad­her­ence, and in turn, un­want­ed preg­nan­cies. Lyn­dra Ther­a­peu­tics is work­ing on the fix — a pill that can be tak­en week­ly, or even month­ly.

In its quest, the Wa­ter­town, Mass­a­chu­setts-based drug de­vel­op­er has scored a $13 mil­lion grant from the Bill & Melin­da Gates Foun­da­tion.

The oral cap­sule is en­gi­neered to de­liv­er a steady stream of es­tro­gen and prog­estin — the drugs used in ex­ist­ing dai­ly com­bined oral con­tra­cep­tives — over sev­en days or more. The for­mu­la­tion, which is de­signed to open once in­side the stom­ach, is de­signed to even­tu­al­ly ex­it safe­ly via the gas­troin­testi­nal tract, like undi­gest­ed food. Lyn­dra, along with non-prof­it part­ner Routes2Re­sults, will con­duct the pre­clin­i­cal stud­ies.

As of 2018, there were 61 mil­lion US women of re­pro­duc­tive age, and four out of five sex­u­al­ly ex­pe­ri­enced women have used the pill, ac­cord­ing to the sex­u­al and re­pro­duc­tive health-fo­cused re­search and pol­i­cy or­ga­ni­za­tion Guttmach­er In­sti­tute. There are var­i­ous oth­er forms of con­tra­cep­tion, in­clud­ing fe­male con­doms, di­aphragm, cer­vi­cal cap, con­tra­cep­tive sponge, pills, vagi­nal ring, con­tra­cep­tive im­plant, con­tra­cep­tive in­jec­tion, birth con­trol patch, in­trauter­ine de­vices and ster­il­iza­tion.

How­ev­er, con­tra­cep­tive sup­plies and ser­vices can be ex­pen­sive. In 2014, an es­ti­mat­ed 20 mil­lion women in the Unit­ed States need­ed fed­er­al or state fund­ing for fam­i­ly plan­ning ser­vices, the Guttmach­er In­sti­tute es­ti­mat­ed. For­mer De­mo­c­ra­t­ic pres­i­dent Barack Oba­ma’s sig­na­ture health­care law, the Af­ford­able Care Act, guar­an­teed the cov­er­age of con­tra­cep­tive meth­ods and ser­vices with no out-of-pock­et costs — but the Trump ad­min­is­tra­tion has en­deav­ored to un­der­mine these pro­tec­tions, cit­ing re­li­gious and moral ex­cep­tions, and has al­so sought to gag Planned Par­ent­hood — the na­tion’s largest abor­tion provider — with a se­ries of an­ti-abor­tion bills.

Bob Langer

Ear­li­er this year, Lyn­dra un­veiled a $60 mil­lion round of fund­ing, with back­ing from the Gates Foun­da­tion. The com­pa­ny — whose tech­nol­o­gy plat­form re­volves around killing dai­ly reg­i­mens in fa­vor of longer-act­ing ther­a­pies — got start­ed at the pro­lif­ic lab of Bob Langer at MIT. Last fall it wrapped up a proof-of-con­cept tri­al for its re­for­mu­lat­ed schiz­o­phre­nia ther­a­py, and ear­li­er this month the com­pa­ny joined forces with Gilead to work on long-act­ing HIV ther­a­pies.

So­cial im­age: Shut­ter­stock

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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En­her­tu picks up an­oth­er win for As­traZeneca and Dai­ichi Sankyo, join­ing the pri­or­i­ty re­view lane for gas­tric can­cer

Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.

The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.

Chi­nese rare dis­ease play­er inks first deal around nar­colep­sy drug Wak­ix af­ter grab­bing $80M to build an ecosys­tem

Two months ago, the narcolepsy therapy Wakix propelled Harmony Biosciences to a $128 million debut on Nasdaq. Now, the same drug is serving as the foundation for a Chinese biotech looking to pioneer a rare disease platform in the country.

Citrine Medicine — which closed $80 million in Series A funding in July — was incubated by F-Prime and Eight Roads, two VC funds affiliated with Fidelity Investments that saw an opening in China to replicate in the vibrant orphan drug landscape in the US (and to a lesser extent, Europe).

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early- and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

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Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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Sci­en­tists warn Amer­i­cans are ex­pect­ing too much from a coro­n­avirus vac­cine

The White House and many Americans have pinned their hopes for defeating the Covid-19 pandemic on a vaccine being developed at “warp speed.” But some scientific experts warn they’re all expecting too much, too soon.

“Everyone thinks COVID-19 will go away with a vaccine,” said William Haseltine, chair and president of Access Health International, a foundation that advocates for affordable care.

No­var­tis CEO Vas Narasimhan signs off on a $231M deal to try some­thing new in the R&D fight against SARS-CoV-2

Patrick Amstutz was baptized by pandemic fire early on.

He and colleagues attended the notorious Cowen conference in early March that included some of the top Biogen execs who helped trigger a superspreader event in Boston. Heading back to his post as CEO of Molecular Partners in Switzerland, the outbreak was sweeping through Italy, triggering near panic in some quarters and creeping into the voices of people he knew, including one friend on the Italian side of the country.

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