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Editor's Note: This column originally published on Dec. 15 predicted European regulatory approval of InterMune's lung drug as the company announced today. Shares of the stock more than doubled on today's news.



) -- I'm pleased to present 15 predictions for the biotech and drug sectors in 2011.

Why 15 predictions in 2011? Why not?

Some of these prognostications are serious, others not so. Almost all would be big surprises were they to come true.


Cell Therapeutics

(CTIC) - Get CTI BioPharma Corp. Report

will increase its share count to 2 billion, followed by a 60:1 reverse stock split. Pixantrone still isn't approved.

2. At least one leading U.S. academic medical center will bar its doctors from consulting with Wall Street investors. Soon after, one or more health care-focused expert networks will shutter operations.




will experience a temporary disruption in Provenge sales due to a problem at one of its manufacturing plants.

4. By the end of the year, one or more of these companies will be gobbled up in an M&A deal:

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(AMRN) - Get Amarin Corp. Plc Report


Seattle Genetics

(SGEN) - Get Seagen, Inc. Report


Human Genome Sciences

( HGSI),




Onyx Pharmaceuticals



Biomarin Pharmaceuticals

(BMRN) - Get BioMarin Pharmaceutical Inc. Report



Arena Pharmaceuticals

(ARNA) - Get Arena Pharmaceuticals, Inc. Report

will end 2011 still trying to convince FDA to approve its weight-loss drug lorcaserin.

6. One of the large-cap biotech companies will begin paying a dividend.




attempt to commercially launch a fetal DNA test for Down's syndrome will be stopped by FDA, which decides to enact stronger regulatory control over all genetic tests.

8. Legislation will be introduced to allow Medicare and/or FDA to consider drug pricing in regulatory approval and reimbursement decisions.

9. European regulators approve



pirfenidone for idiopathic pulmonary fibrosis.

10. After a series of Wikileaks rocks the agency, the FDA decides to make complete response letters (i.e., drug-rejection letters) public.

11. An outraged and unhinged investor physically threatens an expert sitting on an FDA advisory panel, prompting the agency to radically change procedures for future advisory panels. The FDA adds security and does away with definitive "Yes/No" votes for or against drug approvals.


Discovery Labs


finally -- finally! -- receives FDA approval for Surfaxin.



(CVM) - Get CEL-SCI Corporation Report

ends 2011 still searching in vain for the first head-and-neck cancer patient to enroll in the Multikine phase III trial.

14. A Chinese pharmaceutical company makes an unsolicited bid for a large U.S. biotech firm. Or, a large U.S. biotech firm acquires a Chinese pharmaceutical company.

15. A senior

Johnson & Johnson

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executive resigns after a drugstore surveillance camera captures him trying to self-initiate another unofficial recall of children's Tylenol from store shelves.

Happy 2011! If you have predictions of your own for the coming year, please share in the comments section below.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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