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

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.