Martin Shkreli, AP

Mar­tin Shkre­li push­es back on life­time pub­lic com­pa­ny ban from prison cell in bid to get back to busi­ness

De­spite serv­ing his stint be­hind bars, the Mar­tin Shkre­li saga con­tin­ues to sprout legs with new law­suits pop­ping up. Now, in an­tic­i­pa­tion of be­ing a free man once again, Shkre­li is push­ing back on a fed­er­al ban that would seek to keep him out of a pub­lic com­pa­ny’s board­room for the rest of his life.

Shkre­li’s lawyers hope to re­scind the for­mer Retrophin CEO’s life­time ban from the SEC on serv­ing as a di­rec­tor or of­fi­cer of a pub­licly trad­ed com­pa­ny, ar­gu­ing that oth­er dis­graced ex­ec­u­tives have re­ceived much more le­nient 10-year bans, ac­cord­ing to a brief filed in a NY court­room.

The lawyers point­ed to Shkre­li’s sta­tus as a first-time of­fend­er to make the case he like­ly wouldn’t re­peat the white-col­lar mis­con­duct that placed him in prison  and ar­gued that his age — 38 — means a life­time ban “would have a far greater puni­tive im­pact on him than on a sim­i­lar­ly sit­u­at­ed, but old­er, de­fen­dant.”

In ar­gu­ing his case, Shkre­li’s team point­ed the ex­am­ple of for­mer Ther­a­nos head Eliz­a­beth Holmes, who earned a 10-year ban from the SEC de­spite fac­ing fraud charges in fed­er­al court. Holmes, lawyers ar­gued, en­gaged in crimes “a hun­dred times the size of the fraud” Shkre­li com­mit­ted and earned a more le­nient ban. An­oth­er case they point­ed to was Schultz Chan, a for­mer Ake­bia bio­sta­tis­tics di­rec­tor who com­mit­ted in­sid­er trad­ing and was on­ly shut out of serv­ing at a pub­lic com­pa­ny for five years.

Shkre­li’s team al­so ar­gued that he shouldn’t be on the hook for a $1.4 mil­lion fine from the SEC giv­en his on­go­ing sen­tence and the mil­lions he’s al­ready lost in civ­il fine and for­fei­tures.

The idea of Shkre­li, the “phar­ma bro” who de­fraud­ed Retrophin’s in­vestors, get­ting back to busi­ness should be enough to make the biotech in­dus­try’s blood run cold. But even in the mid­dle of his prison sen­tence, Shkre­li’s prob­lems are on­ly start­ing.

In March, Blue Cross Blue Shield of Min­neso­ta sued Shkre­li and Vy­era Phar­ma­ceu­ti­cals — for­mer­ly Tur­ing — over plans to uti­lize what are known as “re­sale re­stric­tions,” pre­vent­ing pro­duc­ers of po­ten­tial Dara­prim gener­ics from ob­tain­ing the nec­es­sary sam­ples of the drug need­ed for FDA eval­u­a­tion. Dara­prim, you’ll re­mem­ber, was the tox­o­plas­mo­sis drug for which Shkre­li jacked up the price and sparked na­tion­al out­rage.

Shkre­li, Vy­era and the oth­er de­fen­dants named — the Swiss biotech Phoenixus and its CEO Kevin Mul­leady — al­so al­leged­ly tried to buy up all the sup­ply of Dara­prim’s ac­tive in­gre­di­ent pyrimethamine, and re­fused ac­cess to the Dara­prim sales da­ta need­ed to de­ter­mine whether a gener­ic prod­uct would be com­mer­cial­ly vi­able.

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.

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.

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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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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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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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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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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