Macro­mol­e­cules in a pill? Tor­toise-in­spired cap­sule of­fers hope in an ear­ly test de­liv­er­ing in­sulin in­to stom­ach wall

For many di­a­bet­ics, nee­dles that de­liv­er their in­sulin are as cru­cial as taps that run the wa­ter they drink. But a team led by MIT and sci­en­tists from No­vo Nordisk — the world’s biggest in­sulin mak­er — are look­ing to change that. Re­port­ed in Sci­ence, the team has cre­at­ed a blue­ber­ry-sized oral cap­sule that de­liv­ers an in­sulin shot in­side the stom­ach once swal­lowed in rats and swine, and are look­ing to take the work in­to hu­mans in three years.

The cap­sule is in­spired by a leop­ard tor­toise — which bran­dish­es a shell that al­lows the African rep­tile to right it­self if it rolls on­to its back. The cap­sule em­u­lates that, so that no mat­ter how it lands in the gut, a nee­dle in­side the pill made of com­pressed freeze-dried in­sulin will ori­ent it­self to come in con­tact with the stom­ach lin­ing. Wa­ter in the stom­ach dis­solves a sug­ar disk hold­ing the nee­dle in­to place, and since the stom­ach wall does not con­tain pain re­cep­tors, the sci­en­tists an­tic­i­pate that pa­tients will not be able to feel the prick.

In an­i­mal stud­ies, the cap­sule was shown to de­liv­er enough in­sulin to low­er blood sug­ar to lev­els sim­i­lar to in­jec­tions ad­min­is­tered through skin, and the de­vice can po­ten­tial­ly be adapt­ed to de­liv­er oth­er pro­tein drugs, such as im­muno­sup­pres­sants used to treat rheuma­toid arthri­tis or in­flam­ma­to­ry bow­el dis­ease or even nu­cle­ic acids in­clud­ing DNA and RNA.

Bob Langer

“(This) new type of cap­sule could some­day help di­a­bet­ic pa­tients and per­haps any­one who re­quires ther­a­pies that can now on­ly be giv­en by in­jec­tion or in­fu­sion,” said MIT’s Robert Langer who was one of the se­nior au­thor’s of the study. Langer’s lab at MIT has spawned a string of bio­phar­ma com­pa­nies.

“(If) a per­son were to move around or the stom­ach were to growl, the de­vice would not move from its pre­ferred ori­en­ta­tion,” said the study’s lead au­thor and MIT grad­u­ate stu­dent Alex Abram­son.

Once in­ject­ed in­to the stom­ach wall, the cap­sule re­leas­es its con­tents, and dis­in­te­grates as it pass­es harm­less­ly through the di­ges­tive sys­tem and is even­tu­al­ly elim­i­nat­ed, the re­searchers said re­fer­ring to an­i­mal da­ta in their re­port pub­lished on Thurs­day.

The re­search was fund­ed by No­vo Nordisk $NVO, the NIH and oth­ers. To be sure, hu­man tri­als are still to come and must be cleared be­fore the de­vice can be safe­ly and ef­fec­tive­ly used. But for the Dan­ish drug­mak­er, the suc­cess­ful de­ploy­ment of the prod­uct could rein­vig­o­rate its long-term growth as it slow­ly moves away from its de­pen­dence of tra­di­tion­al in­jectable in­sulin amidst in­ten­si­fy­ing com­pe­ti­tion and pric­ing pres­sure with­in the di­a­betes mar­ket.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”

Feud be­tween two biotechs left near­ly 12M dos­es of mon­key­pox an­tivi­ral on the ta­ble

As the US embarks on a new delivery strategy to stretch out its thinning supply of monkeypox vaccines, the need for treatments could pick up as cases of the virus rise. And the amount of courses of one potential antiviral, soon to be clinically tested for efficacy in humans, was almost 12 million more than it is today, according to SEC filings.

While not greenlit for treating monkeypox, SIGA’s FDA-approved smallpox antiviral, Tpoxx, can be requested by physicians under an expanded use program. As of Monday, HHS tells Endpoints News it had tapped into more than 15,000 of the 1.7 million courses of Tpoxx that have been stockpiled, but with cases climbing over the past few weeks, demand will likely not peter out in the near future, especially if the vaccine supply runs dry.

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